CN100394886C

CN100394886C - Method and device for detecting medical states in non-invasive way by applying current peripheral arterial tonus control

Info

Publication number: CN100394886C
Application number: CNB2003101237251A
Authority: CN
Inventors: 丹尼尔·A·古尔; 罗伯特·P·施奈尔; 雅各布·谢菲; 佩雷茨·拉维
Original assignee: IT M R MEDIC L CM 1997 Ltd
Current assignee: IT M R MEDIC L CM 1997 Ltd
Priority date: 1996-07-30
Filing date: 1997-07-23
Publication date: 2008-06-18
Anticipated expiration: 2017-07-23
Also published as: AU732592B2; AU3556397A; US6319205B1; WO1998004182A2; IL120881A; CN1228014A; CN1522660A; EP0926980A4; NZ333378A; ATE411768T1; DE69739061D1; EP0926980B1; JP3971457B2; CA2260142A1; US6322515B1; IL120881A0; WO1998004182A3; CA2260142C; JP2000515789A; KR20000029489A

Abstract

A method and an apparatus for non-invasive detection of a physiological state or medical condition are disclosed. The method provides an indication of such state or condition such as myocardial ischemia or sleep apnea, by detecting the peripheral arterial tone's response to such state or condition, based on monitoring changes in peripheral arterial tone and determining that a change in the condition of the patient has occurred when a specific change in the peripheral arterial tone has been detected. A static pressure field is applied around the distal part of a digit of the subject. Peripheral arterial tone changes and related volume changes in the distal part of the digit are detected to thereby detect or monitor a physiological state or medical condition. The apparatus includes a finger probe (20), in the form of a tube (3) accommodating the patient's finger, which is designed to apply pressure, and a contiguous pressure cuff (40) which extends the boundary of the pressure field. The finger probe (2) either includes or is associated with a signal sensor/transducer (100, 101).

Description

The monitoring peripheral arterial tone does not have the method and apparatus of wound diagnosing health situation

The application be 19970723 the applying date, application number is 97196857.8, be entitled as the dividing an application of application for a patent for invention of " method and apparatus that the monitoring peripheral arterial tone does not have wound diagnosing health situation ".

Technical field

The present invention relates to not have the method and apparatus of the detection of wound ground and monitoring physiological state or health status by the monitoring peripheral arterial tone.More particularly, the present invention relates to response is particularly related to the state of the poverty-stricken and blood pressure of cardiopulmonary or situation and the supervision of the vasoconstrictive change of peripheral arterial that causes, thereby detect or monitor patient's physiological status or health status.

As mentioned above, the present invention relates to come various physiological statuss or health status are detected and monitors by the hematodinamics situation that detects the patient body end.Although the present invention relates to detect and monitor many physiological statuss or health status, four kinds of specific examples that relate generally to the poverty-stricken and blood pressure of cardiopulmonary only are provided here, they are myocardial ischemia, sleep period, sleep apnea and continuous blood pressure supervision.Therefore the discussion below comprises the description of the technology that relates to these four kinds of examples.

Relate to the definition of the vocabulary of myocardial ischemia

1, Ischemia: this speech is used for describing the state when the hemoperfusion of organ in the human body is inappropriate.

2, Myocardial ischemia: this speech is used for describing the state when taking care visceral muscle meat ..D.. myocardial ischemia.

3, Angina pectoris(heart pain): the general diagnostic symptom that causes by myocardial ischemia.These symptoms are classified as pain, uncomfortable, chest and/or the compressing of left arm sensation.

4, Atypical angina pectoris: the atypia symptom that the ischemia phenomenon can cause, as in cervical region, molar or other local pain.

5, Asymptomatic angina pectoris: refer to asymptomatic (not pain) myocardial ischemia.In the crowd who continues the ischemia outbreak, have an appointment 20% artificial asymptomatic angor.Therefore, they do not recognize that there is life-threatening problem in they, and they can not remove to seek help from medical treatment device.So there is the danger of sudden death and unexpected death in they.

6, Coronary artery disease: coronary artery is for nourishing the blood vessel of heart.Under arteriosclerotic situation, the expansion of cholesterol volume and the relic of calcification have replaced the normal ingredient of arterial wall and have caused coronary arterial lumen to narrow down.

7, Chronic angina pectoris: in such angina pectoris, ischemic symptom relevant with body kinematics (be and relate to demand).The narrow increase that can not adapt to the heart of work of arteriosclerosis that determine, that can not expand, stiff to the blood demand.

8, Unsettled angina pectoris: in such angina pectoris, the blood clot that forms naturally in the arteriosclerosis section suddenly, partial blockage tremulous pulse unexpectedly, and cause myocardial ischemia.After a while, certain in a flash grumeleuse dissolve naturally, blood perfusion rebulids, myocardial ischemia alleviates.

9, Myocardial infarction: when the grumeleuse that forms not only can not dissolve, develop on the contrary can whole obstruction the thrombosis state time, or the arterial wall of gruel type is when breaking obstructing arterial, the myocardium impaired necrosis of being nourished by relevant tremulous pulse.Here it is myocardial infarction.

10, Arterial tone: the degree of " initiatively nervous " of giving around the smooth muscle fiber of tremulous pulse.State of activation following time (generally by the sympathetic nerve end slightly or blood flow terminal or local meticulous medium activate), these filament contraction, thus reduced the bore of tremulous pulse.When initiatively nervous degree is higher, consequently vasoconstriction; Otherwise, when initiatively nervous degree is low, vasodilation consequently.Except that the active anxiety, arterial wall also presents passive anxiety, and this is owing to endarterial blood pressure.

11, Coronary angiography: coronary artery X-ray radiation video picture practice.Be inserted in arm or the endarterial ductus arteriosus of lower limb by one, a kind of material of radip-opaque is injected into is positioned at endaortic coronary artery starting point place, pass tremulous pulse then and stretch to heart forward.

12, Cardiopulmonary are poverty-stricken: be used for generally describing that major injury owing to cardio-pulmonary function causes to the speech of patient's inferior grade negative effect.This result can be caused by following disease or other disease: myocardial ischemia, valvular heart disease, cardiomyopathy, heart perfusion is bad and chronic lung disease etc.

Concerning patient, if he unsettled angor continue to occur and during with this classical symptom of pain, then diagnosable on the basis of these symptoms is spontaneous ischemia.Generally this patient is implemented coronary angiography and select therapeutic scheme (for example adopting surgical operation, Drug therapy, balloon angioplasty etc.).But, the complaint chest pain people relevant and need determine whether to exist the people of coronary artery disease should make cardiac stress testing for other medical reasons with body kinematics.

In cardiac stress testing, by treadmill, by bike and other exercise with weights strapped to the body or adopt pharmacological method that heart is excited, thereby increase demand to oxygen.Certain methods described herein is suitable for detecting in case the situation of the increase in demand relevant with ischemia in cardiac stress testing.But the excursion of these existing methods predictive values is about 50% to 85%, so they can not become the enough reliable basis or the universal standard of judging disease.

Be elaborating below to the diagnostic techniques that in exercise test, detects myocardial ischemia:

What 1) ECG (electrocardiogram): ECG described is the unusual electrical activity that can occur in the ischemic myocardial zone.Susceptiveness and the specificity of ECG in detecting myocardial ischemia is directly related with the broad range of arteriosclerosis disease.Therefore, the local disease of high risk (promptly being confined to one or two arterial branch place) can be left in the basket at an easy rate.Although in stress test, total the predictive value of ECG only is about 60%, but it still is the chronic anginal most important instrument of detection, and because it is easy to use, cheap, it is the unique effective ways that are used to generally investigate.

2) echocardiography of stress: this technology is based on the two-dimensional ultrasound image of heart wall.In stress test, the myocardial segment that interrelates with the arteriosclerotic coronary artery ischemia that can become.Therefore, the imbalance of cardiac wall motion, for example the minimizing of hypokinesia and/or heart wall thickness can be described by the ultrasound wave cardiography.The continuous improvement of this technology has been brought up to the predictive diagnosis value of stress and has been about 75%-80%, and this value approaches the same with the nuclear medicine imaging technique high.This test can be carried out in doctor's office, but because labor intensity is big, and professional technique is required height, so it is not suitable as large-scale generaI investigation means.

3) nuclear medicine imaging technique

In each nuclear medicine technology that is described below, radiosiotope is injected into intravenous.Among technology b that is described below and the technology c, need after the isotope of injection for the first time be discharged from a period of time during the identical isotope of intravenous injection for the second time, and patient is under the rest state and carries out.This doctor the is distinguished underfilling that causes by infarct area and instantaneous underfilling that in the ischemia section relevant, produces with demand.

To the patient that has the myocardial ischemia relevant in various degree in the diagnostic test of be sure oing to be described below with demand then general recommendations make the catheterization and the coronary angiography of heart.The nocuity maximum of doing like this, but also be the most definite available diagnostic test.In most cases, even the nuclear medicine test is male, final therapeutic scheme is also determined according to this angiography.But under certain conditions, in angiography, find have the patient of diffusivity coronary disease will advise adopting once more one of nuclear medicine diagnostic technology to determine the structural damaged influence of internal organs to function.

A.MUGA (multi-door control angiography): in this method, the label technetium (Tc) of injection is absorbed by the erythrocyte in the blood.Can reflect the cardiac wall motion imbalance of ischemia by the dynamic film imaging of the heart chamber of the blood engorgement that is labeled.The reliability of this test is about 80-83%.

B.201-thallium (T1) flat scanning: the 201-T1 of injection is a kind of radioactive indicator, and it is by dynamic myocardial cell " absorption ".Blocking or pouring in abnormal ischemic area, thallium is no longer absorbed by cardiac muscle, demonstrates underfilling on flat scanning figure.The reliability of this test is about 80-83%.

C. thallium SPECT (single photon emission computerized tomography,SPECT): this is than the more high-grade technology of flat scanning in the thallium imaging.In this technology, underfilling and the temporary ischemic region that is caused by infraction can be separated.In the scanning of after a few hours are finished in scanning for the first time, the carrying out second time, can see picked-up in the ischemic area formerly to radioactive indicator.In case the perfusion relative deficiency relevant with demand disappears, and perfusion rebulids, and then the circulation thallium can arrive and mark once more dabbling cardiac muscle.Current, this method is conventional criteria positive or be used for carrying out clinical ischemia testing after the doctor judges patient in the result of ECG.The reliability of this method is within the 82-85% scope.

D.PET (positron emission computerized tomography): in this method, metabolic activity is by the spike of radioactive label reagent, and this reagent is common participation metabolism circulation as glucose.Metabolism is the sign of life, and is representing the vitality of cardiac muscle.In addition, PET can be used in the perfusion studies.

Although the PET scanning method is the most accurate in the nuclear medicine test, but it is expensive (equipment of millions of dollar and special instrument) very, and the same with other nuclear medicine test, the positive patient of result of the test advises carrying out angiography the most at last to obtain definite treatment conclusion.

Clearly, above-mentioned all technology all are the various function damage situations that are designed to be used for to detect ischemic heart.That is to say that existent method is the function that monitors or detect heart itself, or the dysfunction that causes owing to the lasting existence of ischemia.On the contrary, as described in below inciting somebody to action more fully, what the present invention monitored is the response that the peripheral arterial tonicity takes place myocardial ischemia.

Generally speaking, have two functions to participate in blood pressure (BP) is maintained the psychological need level: 1) cardiac output (CO) rises metering with per minute; And 2) system (with pulmonary comparatively speaking) vascular resistance (SVR), with dyne/second/centimetre ⁵Metering.System's vascular resistance one speech refers to the impedance to mobile blood in system's arterial, and it is regulated by arterial tone.

Relation between blood pressure, cardiac output (CO) and the SVR can probably be represented by formula BP=CO * SVR, and the technology of traditional definite SVR comprises and measure blood pressure and CO, calculates SVR then thus.But co-inventor of the present invention (Goor) has formerly proposed the technology of direct measurement SVR.Referring to the United States Patent (USP) 4,429,701,4,798,211 and 4,821,735 of all authorizing people such as Goor, these patent documentations are cited as a reference at this.At United States Patent (USP) 4,429, a kind of new method and device ..D..D drag measurement meter (Resistometer) that is used for directly monitoring the variation of SVR disclosed in 701.Subsequently, at United States Patent (USP) 4,798, disclose in 211 at percutaneous and monitored SVR through employing drag measurement meter in the coronary angiography (PTCA) of chamber (transluminal), wherein air bag is expansible each time, has generally speaking blocked related coronary artery, and SVR also raises subsequently (referring to people such as Mohr, circulation, 74:780-6,1986).

But the method and apparatus of people's such as the above-mentioned Goor of authorizing patent disclosure is based on direct measurement SVR, and needs invasive technology to measure.Specifically, SVR is by being placed on the femoral artery place with a pin and directly measuring.In addition, although can suppose that SVR does not obtain monitoring with can having wound, also there is not suitable no wound ground directly to monitor the method and apparatus of SVR up to now.

It is known physiological phenomenon that peripheral blood vessel is regulated (vasoregulation).For example it shows as health and generally comes attemperation by the blood flow that change flows to skin, thereby comes regulate body temperature by heat exchange.Like this, increasing to environmental radiation heat, and vasoconstriction has reduced the amount of blood flow to skin to the blood flow that vasodilation makes heat to skin, thereby has preserved heat.Peripheral blood vessel shrinks and also occurs in when traumatic hemorrhage or hemorrhage due to internal injury, thereby guarantees that stable blood pressure and brain, liver, kidney and other major organs have normal blood and supply.Regulation of blood vessels is very accurate process in the body that is undertaken by vasodilation and vasoconstriction, and it is subjected to the control of brain and local medium, and is regulating continuously, to maintain the best perfusion of internal organs of the body under various physiology and the pathologic condition.

The influence of myocardial ischemia and associated death risk can estimate Jewish estimative figure by following in the situation of Western society.Jew is approximately 500 ten thousand, and wherein estimating at 250,000 people is the cardiac.80-85% has coronary artery disease among them.In these known people with coronary artery disease, about 80-90% has chronic angina pectoris.In the patient of these treatments, mortality rate is about 1-2% every year.Remaining 10-20% often is subjected to unsettled anginal puzzlement.In the patient with unstable angina of these treatments, annual mortality rate can reach 10-20%.

The expert of Jew estimates outside 250,000 heart patients except estimation, approximately to also have the people of as much to have the cardiac function disorder and not process diagnosis.This estimation verified by such fact, and promptly 6,000 people that have an appointment die from heart disease every year in Jew, and wherein half is to exceed unexpectedly fully, occurs on the person of not thinking the cardiac.Therefore as can be seen, the main health problem that exists in Western society is that the people who estimates 10-20% has coronary artery disease, and therefore is subjected to various forms of myocardial ischemia puzzlements, presents no pain or other symptom of this disease.

Therefore, tightly need a kind of simple, inexpensive, AT technology to detect owing to the myocardial ischemia that exists coronary artery disease to occur, it have higher predictive value than existing stress ECG testing of being suitable for.

Technology about sleep quality and sleep apnea

General individuality is through having several different sleep period all through the ages.A kind of important sleep period is referred to as the REM sleep, it is characterized by ocular movement fast, little muscle twitches, autonomous action change, and does not have other body kinematics.(NREM) sleep that other sleep period is referred to as not have REM can be subdivided into four phases, wherein the first phase the most shallow, promptly least calmness or energy recover minimum, and the fourth phase is the darkest.

Monitor that individual REM sleep is sleep disordered very important to diagnosing.It in other various aspects also of great use, as and all of great use to the reaction after treatment depression and the narcolepsy that obviously reduces REM incubation period and research in treatment, diagnosis.

For diagnosis, should monitor patient's sleep, so that determine the pattern and the time-continuing process of various sleep period.Employing electrophysiological technique and electronic machine come the signal of telecommunication of the activity generation of brain and muscle is measured, thereby the quality and the quantity of sleep are assessed.

The technology that is used for the extensive employing of this purpose comprises electroencephalogram (EEG) data that real-time continuous is measured.The EEG data are the main signal that obtains from the cortex of brain, and are called electrocorticogram (ECoG).Measure simultaneously and generally result from electromyographic signal (being used to monitor musculation) and the left eye that produces by the eye motion and an electro-oculogram signal (EOG) of right eye in the lower jaw muscle.These EEG, EMG and EOG signal are recorded on traditional multichannel physiograph.

Camera technique also has been used for judging sleep period.According to people such as Hobson (science 201,1978, p.1251-5) argumentation, the activity that is in the measured in the sleep be by photographic measurement, and mainly occur in according to the transformation of body posture and to enter and finish prerequisite in the REM sleep and predict conversion between NREM and the REM.

United States Patent (USP) 4,784,162 have described a kind of equipment that is used to monitor dyssomnias, and this equipment has adopted a plurality of pick offs on one's body attached to patient that are suitable for.Pick off produces analogue signal, and this signal sequence converts binary data to and transmits by low-energy radiation.United States Patent (USP) 4,784,162 method and apparatus of describing adopt electronic filters to represent the eye motion and carry out filtering by the analogue signal attached to the head movement of the acquisition of the detecting head on the headwear, thereby report individual sleep state.

The United States Patent (USP) 5,280,791 of authorizing co-inventor Lavie of the present invention relates to a kind of dormant system that is used for determining the people, and this system comprises: the device of (a) measuring human heart R wave spacing; (b) calculate the power spectrum of heart R wave spacing, thereby obtain the device of the ratio of power spectrum between the high and low frequency; (c) in response to the measurements and calculations device, produce the device of output signal, when characterizing the REM sleep, output signal has first value, and when above-mentioned ratio was lower than the threshold value that characterizes the NREM sleep, output signal had second value; And, characterize the device in the cycle of REM cycle or non-REM cycle predetermined lasting time respectively (d) in response to output signal.Preferably the scope of power spectrum concerning low frequency generally between 0.01 to 0.07Hz, concerning high frequency between 0.2 to 0.3Hz.

Sleep apnea syndrome is one of the most common, serious sleep imbalance disease.It is characterized in that in sleep procedure although the breathing of lasting stability is arranged, upper respiratory tract obstruction occurs repeatedly, thereby gas communication is interrupted.The asphyxia that causes obstruction typically links together with ever-increasing suffocating, and up to from the temporary transient awakening of sleep state and finish, and upper respiratory tract obviously recovers unobstructed.Extensive studies (being carried out in the inventor's laboratory by the inventor and other people) has been made estimation, and the people of 2-4% has sleep apnea syndrome among the crowd that grows up.Determined that this syndrome is the important risk factor of systolic hypertension, myocardial infarction, apoplexy and sudden death.In order to diagnose sleep apnea, generally writing down electromyographic signal (EMG) under EEG signals (EEG), electro-oculogram signal (EOG), the jaw, mouth nose air-flow (adopting electro-hot regulator or thermocouple) and breast abdominal exercise (employing breathing zone), sound of snoring intensity (adopting the dB meter), pulse oximetry value and leg exercise on the multichannel recorder simultaneously.Whole apnea write down truly in each record.This record is pretty troublesome, and may bother patient's sleep.

In view of the difficulty of existing sleep assessment technique, therefore only carry out part in many cases and monitor, comprise effect of breathing and blood oxygen quantitative values.Partial record mainly is to be used to screen purpose.Their purpose is the people who is used to determine to exist a large amount of apnea.

Therefore, be necessary to provide a kind of simple method to detect sleep period and sleep apnea syndrome, it allows patient can cosily be in sleep state in evaluation process.

The background technology that relates to blood pressure

Many diagnosis and therapeutic process need accurately, the systolic arterial pressure and the diastolic pressure of monitoring blood pressure, particularly system consistently, and also need to obtain the shape of mean blood pressure and pulse wave often.The method and apparatus of existing monitoring blood pressure generally can be divided into two kinds on no wound type and intrusion type.AT method is used for shrinking and the regular single measurement of diastolic blood pressure data enough the time when tremulous pulse.The intrusion method be used for when needs reliably, when measuring blood pressure continuously, maybe when needing the shape of pulse wave.The method that traditional continuous blood pressure is measured comprises importing intra-arterial intubate, and this intubate is transferred to pressure measuring device with endarterial pressure waveform.Because it is an intrusive mood, present continuous monitoring is subjected to critical nursing and the limited environmental limit of operating room.If yet easy to use, the reliable and stable no wound method that is used for continuous monitoring is available words, wish that under many situations carrying out continuous blood pressure measures.

The method that the most public no wound is measured blood pressure is to adopt the method for under-chin and oscillograph formula sphygmomanometer.According to this method, with a hoop be placed on the upper arm place and the inflation, up to tremulous pulse by total blockage.Adopt then a sound detection device detect block and the pressure minimizing process of hoop in pulse signal.As well-known, these methods only provide the value of systolic pressure and diastolic pressure, and are not suitable for the continuous blood pressure measurement.Therefore another major defect of these methods tremulous pulse that has been their total blockages has disturbed normal blood flow.Also known in addition these methods are particularly concerning fat or have and can make mistakes the arteriosclerotic people; And be unsuitable for the patient that is used for sleeping, come because measuring process might make patient wake up; This method uses very inconvenient in motor process in addition.In addition, the data that these methods provide seldom, and to unstable blood pressure resolution pole is low qualitatively.

A kind of method of existing continuous monitoring blood pressure is to measure tensile method, and it is based on the measurement to the arteriogram of external record.In other words, adopt a device to come peripheral arterial is applied the given power of a size, monitor that simultaneously the ripple amplitude of tremulous pulse changes.The main drawback of this prior art is that it can not be used for continuing accurate the measurement, and can not carry out long-time, accurate blood pressure measurement.Particularly this method is very sensitive to the mechanic effect of patient's motion, thereby has limited its effectiveness.

Another subject matter of this method is to lack the accurate device that force signal is converted to pressure signal.Particularly exist at least following two kinds former thereby hindered and find out blanket transforming factor.The first, it is widely different that pulse wave is transferred to when external each body.The second, the relation between power/pressure may be non-linear, and like this, the systolic pressure and the diastolic blood pressure values that are obtained by the sphygomanometer independent measurement can not be used for suitable calibration.

The method of another kind of existing continuous monitoring is the Penaz method.The internal arteries pressure at balance patients fingers place is wanted in this method instruction, continuously changes outer counter pressure simultaneously, thereby the optical density (OD) at finger place is maintained on the constant level, so that come monitoring blood pressure to change.Clearly, this method relies on the basic horizontal with external pressure to remain on level near intra-arterial pressure, and the continuous application of this external pressure is undesirable.This method is also very sensitive to patient's motion.The inventor believes, at least one reason that this method produces deviation is, the higher relatively pressure of lasting application will change the venous return at place, measuring position, thereby cause the venous congestion at place, finger tip part measuring position, the reflexive that might cause change on the hematodinamics and vascular like this changes, thereby causes the variation of blood pressure measurement.

Another kind of existing method is to adopt to comprise that a light transmission and one are placed on the photograph plethysmography device of optical receiver of the opposite side of finger tip.Receptor is noted the optical transmission that sees through finger that the variation by the intra-arterial blood flow causes and is changed.The signal that receives transfers in the computer, and this computer converts the output signal of receptor to systolic pressure and diastolic blood pressure data.An obvious drawback of this method is to lack the precise calibration device that the output signal that light is changed converts blood pressure to.And the influence of venous blood in the finger is uncertain, and the influence of venous blood is attack as hereinafter described basically.

Therefore, need provide a kind of simple, AT technology to carry out continuous blood pressure monitors.

As will be described later in detail, the inventor has be sure of can be by detecting to determine physiological status or health status to the outer feature hematodinamics phenomenon of patient body.Especially, the inventor proves that cardiopulmonary are poverty-stricken not only can also can be detected by the progress that direct measurement peripheral blood vessel shrinks and monitor by measuring the SVR that raises.This method that makes the noinvasive triage survey should use very easy, and cheap.

Therefore, the purpose of this invention is to provide a kind of AT method and apparatus, this method and apparatus can detect accurately, consistently physiological status or health status by the variation that detects the peripheral arterial tonicity that certain effect of bringing out of response produces.

The present invention's purpose more specifically provides a kind of by detecting and the monitoring peripheral vasoconstriction detects the poverty-stricken method and apparatus of cardiopulmonary.

Although having known arterial tone is the mechanism that human body is used for controlling various functional parameter, the inventor proves that the variation of arterial tone can be used as the useful diagnostic tool of physiological function disorder or health status.More particularly, the inventor proves, can shrink by direct measurement peripheral blood vessel and detect the physiological function disorder, as myocardial ischemia etc., wherein to shrink be to cause having been found that in the people's such as Goor that quote as proof above the patent and original factor that the SVR that reports raises to peripheral blood vessel.

Therefore, disclosed herein is the method and apparatus that is used to not have wound monitoring peripheral arterial tone.Although the variation of peripheral arterial tonicity can be by monitoring other multiple hemodynamic parameter of any peripheral arterial, variation as the shape of blood flow, blood volume and arterial pulse wave detects, but preferably is guided out the variation that signal detects the pulsating quantity of this place arterial blood at patient's finger or toe place.Can wait to determine the variation of tremulous pulse blood volume as volume, the optical density (OD) of finger by one or more parameters of plethysmography.Finger is a preferred positions, because it is easy to contact, but also can utilize other zone of body extremity.

In the preferred structure of present device, this equipment comprises that an admittance comprises the finger detecting head of the whole or regional area of patients fingers far-end.The finger detecting head comprises that one is the inflexibility sleeve pipe of shell shape and the submissive film of a finger shape that is altex glove basically.An annular adds pressure zone with this film separated into two parts, adds crimp by an air bag and one basically and forms.But a U-shaped metal bar is divided into air bag the compartment of two transmitter substances.These two compartment act on the distal portions of finger, then pressurization.Adding crimp pressurizes from the compartment of air bag respectively.In a preferred embodiment, pressure should be enough to prevent produce venous congestion at the place, measuring position, can eliminate the tension force on the arterial wall simultaneously again.But institute's applied pressure can not be high to having blocked tremulous pulse.The finger detecting head can comprise the device that is used to detect the arterial tone variation, for example pressure transducer or photoelectric cell etc.In addition, the finger detecting head can comprise that the information that is used for sensing is sent to the conduit that is positioned on the outer pick off of detecting head.

Obviously, method and apparatus of the present invention is suitable for detecting and monitoring various physiological statuss and health status, particularly myocardial ischemia.For example, the inventor proves that method and apparatus of the present invention is applicable to two importances in the sleep supervision: rapid eye movement (REM) sleep period and sleep apnea syndrome.

In addition, the inventor proves, and equipment of the present invention can be used for the sleep crowd generally investigated and detects peace and quiet or significantly angina pectoris at night.This point prior art is not accomplished, because all prior aries all are pretty troublesome, may disturb patient's sleep.In addition, all existing methods include the good equipment of quality, thereby very expensive, so be not suitable for generaI investigation.

After some distortion and adopting novel calibration program, proved that the present invention is suitable for continuous, the no wound measurement of blood pressure.

Illustrate the present invention now in conjunction with the accompanying drawings, wherein:

Fig. 1 is a profile, illustrates in general on the finger or toe (for example finger) that is applied to the measured, so that an embodiment of the detecting head of the present invention of supervision measured's peripheral arterial tonicity;

Fig. 2 a and 2b show another embodiment of detecting head shown in Figure 1;

Fig. 3 a is the longitudinal sectional drawing that is configured to add accordingly with one embodiment of the present of invention crimp, and Fig. 3 b is the profile that A '-A ' line is cut open along Fig. 3 a;

Fig. 4 a shows the detecting head shown in Fig. 2 a and the 2b, and Fig. 4 b shows the crimp that adds shown in Figure 3, and the end cover that add crimp and Fig. 2 a and 2b this moment links together, and is in user mode;

Figure 5 shows that the present invention adds another embodiment of crimp;

Figure 6 shows that the present invention adds the another embodiment of crimp;

Embodiment shown in Fig. 6 a-6e is being used for not needing air bag in the measuring process for adding crimp;

Fig. 7,7a and 7b show the preferred embodiment that the present invention points detecting head, wherein end cover and add crimp and merge into a single finger detecting head;

Fig. 8 shows one embodiment of the present of invention, and wherein a plurality of finger detecting heads are inserted in the glove, and have showed a tubulose clamper that is used for fixing the finger of no detecting head among the figure;

Fig. 9 the present invention includes the sketch map of detecting head at an embodiment of interior whole system;

Figure 10 has showed the hand-operated pneumatic system that substitutes automatic pneumatic system shown in Figure 9;

Figure 11 has showed that the present invention points another embodiment of detecting head, and wherein detecting head comprises optical pickocff;

Figure 12-20 is some pictorial data, show when adopting the present invention to detect myocardial ischemia and the result, when also having some to adopt prior arts to detect myocardial ischemia simultaneously and correction data come to compare with The above results;

Figure 21 and 22 is some pictorial data, shows the sleep quality that adopts the present invention to monitor the measured, the result when particularly detecting REM (rapid eye movement) phase and sleep apnea;

Figure 23 shows the embodiment that the present invention is used for carrying out the device that continuous blood pressure measures;

Figure 24 and 25 is depicted as the clinical data curve that obtains in the calibration process to the illustrational apparatus of the present invention of Figure 23; And

Figure 26 and 27 is depicted as the data and curves that gets when adopting blood pressure measurement technology of the present invention to compare with the standard-sphygmomanometer technology.

Specific embodiments

A first aspect of the present invention provides a kind of method that wound ground detects the variation of patient physiological condition of not having, comprise the variation of monitoring peripheral arterial tone, and when detecting peripheral arterial tonicity generation specific change, determine the step of the variation that patient's physiological status has taken place.

It is one of following that described according to a first aspect of the invention method, wherein said physiological situation comprise: myocardial ischemia, REM sleep state begin and sleep apnea.

Described according to a first aspect of the invention method also comprises the step of being exerted pressure in the measuring position, and described pressure enough (a) prevents that basically venous blood from depositing in described measuring position; (b) prevent from basically uncontrolled venous return to take place in described measuring position; And (c) be in and heart on same horizontal plane or when being lower than heart when the measuring position, part is eliminated the tension force at place, described measuring position arterial wall, but obstructing arterial not.

Described according to a first aspect of the invention method, wherein the step of monitoring peripheral arterial tone variation comprises the variation of monitors skin artery blood flow.

Described according to a first aspect of the invention method, wherein the step of monitoring peripheral arterial tone variation comprises the variation that monitors finger or toe artery blood flow.

A second aspect of the present invention provides a kind of being used for to detect the equipment that patient changes, and comprising:

A detecting head that is applied to patients fingers or toe, the peripheral arterial tonicity of described detecting head finger sensing or toe; And

A processor, this processor receive from the signal of described detecting head and the variation of the peripheral arterial tonicity that shows described finger or toe are provided, thereby show patient's the physiological status or the output signal of health status.

Described according to a second aspect of the invention equipment, wherein said detecting head comprise a film that is used for exerting pressure, and this pressure enough (a) prevents that basically venous blood is in described finger or the alluvial of toe place; And (b) part is eliminated the tension force of described finger or toe place arterial wall, but obstructing arterial not.

Described according to a second aspect of the invention equipment, wherein said equipment comprise that also is used for monitoring the pick off that described finger or toe place blood volume change.

Described according to a second aspect of the invention device, wherein said detecting head comprise that also adds a crimp.

A third aspect of the present invention provides a kind of detecting head that shrinks with the detection peripheral blood vessel on finger or the toe that is applied to, and described detecting head comprises:

A film of exerting pressure, the enough parts of described pressure are eliminated the tension force of described finger or toe place arterial wall, but obstructing arterial not,

Be used for preventing basically the device of venous blood in described finger or the alluvial of toe place.

Described according to a third aspect of the invention we detecting head comprises that also is used for monitoring the pick off in described finger or the variation of toe place blood flow volume.

A kind of method that wound ground detects patient's physiological function obstacle of not having is provided according to a forth aspect of the invention, comprises:

At measured's the finger or the far-end of toe, the finger or the toe tip that are included in distal-most end apply a static pressure field of force on every side, and this static pressure field of force enough (a) prevents that basically venous blood from depositing at described far-end; (b) prevent from basically uncontrolled venous return to take place at described far-end; And (c) when finger or toe and heart are in same horizontal level, part is eliminated the tension force of described distal artery wall, but obstructing arterial not; And

Measure the variation of peripheral arterial tonicity and in the variation of the described far-end of finger or toe corresponding to the correlative that takes place with arterial pulse wave.

Described according to a forth aspect of the invention method, the variation of wherein said correlative measures by the change in volume of measuring at described far-end.

Described according to a forth aspect of the invention method, the variation of wherein said related volume measures by the optical density (OD) variation of measuring at described far-end.

Described according to a forth aspect of the invention method, the variation that wherein monitors the described amount that records is to show existing of patient's myocardial ischemia.

Described according to a forth aspect of the invention method monitors that wherein the variation of the described amount that records begins and be in a kind of situation and the sleep apnea of this sleep state to show rapid eye movement (REM) sleep at least.

Described according to a forth aspect of the invention method, the scope in the wherein said static pressure field of force are that about 30mmHg is to being higher than patient's diastolic pressure about 10%.

Described according to a forth aspect of the invention method, the wherein said static pressure field of force is applied to around the proximal part of finger, is included in the most advanced portion of finger.

Described according to a forth aspect of the invention method, the wherein said static pressure field of force is applied by canular detecting head, and this detecting head comprises the end cover of a distal-most end of sealing phalanges or phalanx at least and the annular collar of an adjacency.

Described according to a forth aspect of the invention method, the pressure in the wherein said static pressure field of force is 70mmHg.

Provide one to be used for detecting the detecting head that the peripheral arterial tonicity changes according to a fifth aspect of the invention, comprising:

An end cover that is used for admitting patient's finger or toe, described end cover has a pressure compartment, and the setting of this compartment makes pressure be presented on the phalanges of distal-most end or the opposite side of phalanx, thereby prevents that venous blood is in described finger or the alluvial of toe place;

One adds crimp, and this adds crimp and has a film, and the setting of this film makes pressure be presented on the phalanges or the phalanx place of the distal portions of above-mentioned finger or toe, thereby prevents that venous blood is in described finger or the alluvial of toe place;

A pick off that is used for detecting in described phalanges or phalanx distal-most end place arterial pulse change in volume.

Described according to a fifth aspect of the invention detecting head also comprises a heating arrangements.

Described according to a fifth aspect of the invention detecting head also comprises a pick off of experiencing vertical displacement.

Described according to a fifth aspect of the invention detecting head, wherein said pressure compartment is limited by a deformable tubular film, and wherein said detecting head comprises that also one prevents the device of described film axially-movable when pressurization, thereby avoids extruding the finger that is placed in the detecting head.

Described according to a fifth aspect of the invention detecting head, wherein said deformable tubular film are divided into two parts of the opposite side that is positioned at finger diametrically.

Described according to a fifth aspect of the invention method, wherein said end cover are divided into a plurality of overcoat parts, and each described overcoat partly has a membrane portions that is attached thereto, and wherein said a plurality of overcoat partly connects together and constitutes described end cover.

Described according to a fifth aspect of the invention detecting head is used for wherein preventing that the described device of described film axially-movable from comprising installation containment rod on the coat, and this containment rod has the mid portion that is contained in the tubular film, thus the inside axially-movable of containment membrane.

A kind of method of demarcating blood pressure measuring instrument is provided according to a sixth aspect of the invention, comprise by changing measurement point and bring out with respect to the upright position of heart and monitors static pressure variation in tested arteries, and other amount of measuring corresponding amount and being associated with this arterial vascular feature is marked and drawed these measured values then and is changed the compliance curve that generates these blood vessels with the static pressure that brings out.

The method of a kind of measured's of measurement arteriotony is provided according to a seventh aspect of the invention, comprises:

The finger of measured's health or the far-end of toe are heated to predetermined temperature, the arteries at described finger or toe place is expanded to greatest extent;

Measure the correlative variation of stating far-end with corresponding finger of blood pressure ripple or toe place;

Convert described measured change to arteriotony.

Described according to a seventh aspect of the invention method, wherein around the far-end of finger or toe, apply the static pressure field of force, this pressure enough prevents the venous blood alluvial basically, and when finger or toe and heart can partly be eliminated the tension force of finger or toe place arterial wall on same horizontal plane or when being lower than heart, but obstructing arterial not.

Described according to a seventh aspect of the invention method, the wherein said amount that records be changed to far-end and the corresponding change in volume of blood pressure ripple at described finger or toe.

Described according to a seventh aspect of the invention method, being changed to of the wherein said amount that records in the far-end of described finger or toe and the variation of the corresponding optical density (OD) of blood pressure ripple.

Described according to a seventh aspect of the invention method, wherein the variation in the amount that records of the finger or the far-end of toe is converted into arteriotony in the following way:

Finger or toe are applied the described static pressure field of force as a predetermined outer counter pressure;

To point or toe vertically is placed on a plurality of upright positions with respect to measured's heart;

Measuring measured's finger or toe is in respect to time on each upright position of measured's heart and is superimposed upon static pressure on measured's the blood pressure;

Demarcate about the variation of measured's arteriotony with described predetermined external counter-pressure and described static pressure measurement value, and convert the variation of the described amount that records to arteriotony in the described amount that records of the outboard end of measured's finger or toe.

A kind of detecting head that is used for measuring measured's peripheral arterial tonicity is provided according to an eighth aspect of the invention, comprises:

Rigidity overcoat with an opening and a blind end;

A submissive film that is positioned at described overcoat and is connected to the opening of described overcoat airtightly;

An annular that is arranged in the described overcoat adds pressure zone, and the configuration of this band is used for described film pressurization is made it to be affixed to the inwall of described overcoat;

A containment rod that is essentially U-shaped, this containment rod is positioned at overcoat, and it is arranged to pasting film, thereby prevents that film moves axially when film expands, so that avoid extruding the finger that is placed on the there.

Described according to an eighth aspect of the invention detecting head, the wherein said pressure zone that adds is divided into two gastight pressurizing chambers with described film.

Described according to an eighth aspect of the invention detecting head also comprises an optical pickocff.

A kind of equipment that is used to monitor measured's arterial pulse wave is provided according to a ninth aspect of the invention, comprises:

A pressure applicator that comprises a tubular sleeve, this tubular sleeve are used for admitting a predetermined length of the far-end of the finger of measured's health or toe, comprise the tip farthest of finger or toe;

A pressurized source, when described tubular sleeve is admitted the far-end of finger that measured's health is arranged or toe, this pressurized source applies the static pressure field of force around the far-end of described finger or toe, this static pressure field of force is enough to prevent basically to point or the venous blood alluvial at toe place, and when finger or toe and heart are on same horizontal plane, this static pressure field of force is enough to the tension force that part is eliminated this place's arterial wall, but obstructing arterial not; And

A described far-end and the corresponding measuring device that changes of blood pressure ripple that is used for measuring finger or toe.

Described according to a ninth aspect of the invention equipment, what wherein said measuring device was measured is the described far-end and the corresponding change in volume of blood pressure ripple of finger or toe.

Described according to a ninth aspect of the invention equipment, what wherein said measuring device was measured is finger or the described far-end of toe and the variation of the corresponding optical density (OD) of blood pressure ripple.

Described according to a ninth aspect of the invention equipment, the static pressure field of force that wherein said pressure applicator applies around the finger or the far-end of toe from the position of measuring described variation with towards the direction of heart proximal extension one preset distance toward finger or toe.

Described according to a ninth aspect of the invention equipment, wherein said pressure applicator comprises:

An overcoat, this overcoat have a deformable tubular film of installing within it, and this tubular film limits a tubular cavity with overcoat; And

A pressurized with fluid source, this pressurized source applies fluid pressure to described tubular cavity, thereby cause tubular film according to there by the variation of blood flow in the measured's who receives finger or the toe and be out of shape;

Wherein said deformable tubular film is divided into a plurality of parts.

Described according to a ninth aspect of the invention equipment, wherein said deformable tubular film are divided into two parts of the radially relative both sides that are positioned at the measured's finger this place admitted or toe.

Described according to a ninth aspect of the invention equipment, wherein said overcoat is divided into a plurality of parts, connects together with each described membrane portions separately, and limits described outer tubular chamber with described membrane portions.

Described according to a ninth aspect of the invention equipment, wherein said tubular film is divided into described a plurality of part by installation containment rod on the coat, this containment rod has a mid portion that is contained in the tubular film, thereby in the inside motion of the outer periphery that when described tubular cavity applies described fluid pressure, suppresses each membrane portions.

Described according to a ninth aspect of the invention equipment, the pressure limit in the static pressure field of force that wherein said pressurized source provides are from 30mmHg to about 70mmHg.

Described according to a ninth aspect of the invention equipment, wherein said equipment comprise that also one will be pointed or the variation of the described amount that records at the described outboard end place of toe converts the transducer of measured's arteriotony to.

Described according to a ninth aspect of the invention equipment, wherein said transducer comprises:

A measuring device, when pointing or toe vertically is positioned on a plurality of upright positions with respect to measured's heart, this measuring device is used for measuring the static pressure on the pressure value that is superimposed upon the measured; And

A computer, the outboard end place that this computer utilizes the described static pressure field of force and described static pressure measurement value to demarcate measured's finger or toe is relevant to the variation of the described amount that records of measured's blood pressure, and converts the described variation that measures to arteriotony.

Described according to a ninth aspect of the invention equipment, wherein said equipment also comprise a pre-heater, and this pre-heater is used for described finger or toe are preheated to predetermined temperature, thereby the arteries at described finger or toe place is at utmost expanded.

Described according to a ninth aspect of the invention equipment, wherein said pressure applicator are combined at least one fingerstall of the glove that had on by the measured, and measure measured's finger tip in this fingerstall be inserted in glove corresponding to the variation of blood pressure ripple.

A kind of equipment that is used for monitoring measured's hematodinamics situation is provided according to the tenth aspect of the invention, comprises:

A heater, this heater are used for the described finger of measured's health or toe far-end are heated to predetermined temperature, thereby the arteries at described finger or toe place is at utmost expanded;

One is used for measuring at finger or the toe far-end measuring device corresponding to the variation of pressure wave.

Described according to the tenth aspect of the invention equipment, also comprise a pressure applicator, this pressure applicator is used for applying a static pressure field of force around the far-end of finger or toe, the pressure of this pressure field enough prevents the alluvial of venous blood basically, and can when finger or toe and heart are in same horizontal level, partly eliminate the tension force of finger or toe place arterial wall, but obstructing arterial not.

Described according to the tenth aspect of the invention equipment, wherein said measuring device is measured is the change in volume corresponding to the blood pressure ripple at the distal portions of finger or toe.

Described according to the tenth aspect of the invention equipment, wherein said measuring device is measured is that the optical density (OD) corresponding to the blood pressure ripple at the distal portions of finger or toe changes.

A kind of poverty-stricken equipment of measured's cardiopulmonary that is used for detecting is provided according to an eleventh aspect of the invention, comprises:

A pressurized source, when described tubular sleeve is admitted the far-end of the finger that has on measured's health or toe, this pressurized source applies the static pressure field of force around the far-end of described finger or toe, this static pressure field of force is enough to prevent basically to point or the venous blood alluvial of the far-end of toe, and when finger or toe and heart are on same horizontal plane, this static pressure field of force is enough to the tension force that part is eliminated this place's arterial wall, but obstructing arterial not;

One is used for measuring the measuring device of the described far-end of finger or toe corresponding to the variation of blood pressure ripple;

An indicator, when the described variation that measures surpasses that measured's known normal condition when not existing with cardiopulmonary are poverty-stricken is compared and during the predetermined percentage that draws, the poverty-stricken existence of these indicator indication cardiopulmonary.

A kind of dormant equipment of measured that is used for monitoring is provided according to a twelfth aspect of the invention, comprises:

A pressurized source, when described tubular sleeve is admitted the far-end that finger or toe are arranged, this pressurized source applies the static pressure field of force around the far-end of described finger or toe, this static pressure field of force is enough to prevent basically to point or the venous blood alluvial at toe place, and when finger or toe and heart are on same horizontal plane, this static pressure field of force is enough to the tension force that part is eliminated this place's arterial wall, but obstructing arterial not;

An indicator of utilizing the described variation that measures measured's sleep state to be provided indication.

According to the of the present invention the tenth and ten described equipment on the one hand, wherein said measuring device is measured is the change in volume corresponding to the blood pressure ripple at the outboard end of finger or toe.

According to the of the present invention the tenth and ten described equipment on the one hand, wherein said measuring device is measured is that the optical density (OD) corresponding to the blood pressure ripple at the outboard end of finger or toe changes.

According to the described equipment of the of the present invention the tenth and ten one side, wherein said pressure applicator applied pressure scope is 30mmHg to 70mmHg.

According to the of the present invention the tenth and ten described equipment on the one hand, the static pressure field of force that wherein said pressure applicator applies around the far-end of finger or toe from the position of measuring described variation with towards the direction of heart proximal extension one preset distance toward finger or toe.

According to the described equipment of the of the present invention the tenth and ten one side, wherein said pressure applicator comprises an overcoat, this overcoat has an installation deformable tubular film within it, this tubular film limits an outside tubular cavity with overcoat, and the tubular sleeve of described inboard is used for admitting the measured to point or the described far-end of toe;

Described pressurized source applies the static pressure field of force to described outside tubular cavity, thus cause tubular film according to the measured's who is admitted there finger or toe corresponding to the change in volume of blood pressure ripple and be out of shape;

Described deformable tubular film is divided into some a plurality of parts around it when the finger of admitting the measured or toe, each part comprises a middle section and an outer periphery, the outer periphery of each part is suppressed and can not inwardly moves, the degree that the middle section of each membrane portions is moved inward at the pressure of outboard tube shape intracavity is greater than the outer periphery zone like this, therefore cause that the described middle section that moves inward of a plurality of membrane portions sticks device measured's finger or toe tightly, device can not be taken place axially and radial motion with respect to the distal-most end of health.

According to the of the present invention the tenth and ten described equipment on the one hand, wherein said deformable tubular film is divided into two parts of the radially relative both sides that are positioned at the measured's finger admitted in this place or toe.

According to the described equipment of the of the present invention the tenth and ten one side, wherein said overcoat is divided into a plurality of parts, connect together with each described membrane portions separately, and limit described outer tubular chamber with described membrane portions, each described membrane portions formation has four lateral films substantially, and the neighboring of the overcoat part that this film is corresponding with it in its neighboring is fixed together.

According to the described equipment of the of the present invention the tenth and ten one side, the containment rod that wherein said tubular film is mounted on the coat is divided into a plurality of parts, this containment rod has the mid portion that is contained in the tubular film, thereby when the inside axially-movable of outer periphery that when described outside tubular cavity applies described fluid pressure, can contain each membrane portions.

According to the described equipment of the 8th, ten and ten one side of the present invention, wherein said pressure applicator applied pressure is 70mmHg.

Specifically, the invention provides:

1. equipment that is used to monitor measured's arterial pulse wave comprises:

A pressurized source, when described tubular sleeve is admitted the far-end of finger that measured's health is arranged or toe, this pressurized source is at the far-end of described finger or toe, the finger or the tiptoe that comprise distal-most end apply the static pressure field of force on every side, this static pressure field of force is enough to prevent to point or the venous blood alluvial at toe place, prevents venous return, and when finger or toe and heart are on same horizontal plane, this static pressure field of force part is eliminated the tension force of this place's arterial wall, but obstructing arterial not; And

2. as 1 a described equipment, what wherein said measuring device was measured is the described far-end and the corresponding change in volume of blood pressure ripple of finger or toe.

3. as 1 a described equipment, wherein said pressure applicator applied pressure is 70mmHg.

4. as 1 a described equipment, what wherein said measuring device was measured is finger or the described far-end of toe and the variation of the corresponding optical density (OD) of blood pressure ripple.

5. each described equipment as among the 1-4, the static pressure field of force that wherein said pressure applicator applies around the far-end of finger or toe from the position of measuring described variation with towards the direction of heart proximal extension one preset distance toward finger or toe.

6. as each described equipment in the item 1 to 4, wherein said pressure applicator comprises:

Described pressurized source, this pressurized source is exerted pressure to described tubular cavity, thereby cause tubular film according to there by the variation of blood flow in the measured's who receives finger or the toe and be out of shape;

Wherein said deformable tubular film is divided into a plurality of parts.

7 as 6 described equipment, wherein said deformable tubular film is divided into two parts of the radially relative both sides that are positioned at the measured's finger admitted in this place or toe.

8. as 6 a described equipment, wherein said overcoat is divided into a plurality of parts, connects together with each described membrane portions separately, and limits described outer tubular chamber with described membrane portions.

9. as 6 a described equipment, wherein said tubular film is divided into described a plurality of part by installation containment rod on the coat, this containment rod has a mid portion that is contained in the tubular film, thereby in the inside motion of the outer periphery that when described tubular cavity applies described pressure, suppresses each membrane portions.

10. as 1 a described equipment, the pressure limit in the static pressure field of force that wherein said pressurized source provides is from 30mmHg to 70mmHg.

11. as 1 described equipment, wherein said equipment comprises that also one will be pointed or the variation of the described amount that records at the described outboard end place of toe converts the transducer of measured's arteriotony to.

12. as 11 a described equipment, wherein said transducer comprises:

Another measuring device, when pointing or toe vertically is positioned on a plurality of upright positions with respect to measured's heart, this measuring device is used for measuring the static pressure on the pressure value that is superimposed upon the measured; And

13. as 11 a described equipment, wherein said equipment also comprises a pre-heater, this pre-heater is used for described finger or toe are preheated to predetermined temperature, thereby the arteries at described finger or toe place is at utmost expanded.

14. as 1 described equipment, wherein said pressure applicator is combined at least one fingerstall of the glove that had on by the measured, and measures measured's finger tip in this fingerstall that is inserted in glove corresponding to the variation of blood pressure ripple.

15. be used for monitoring the equipment of measured's hematodinamics situation, comprise:

A tubular sleeve is used to admit the finger of measured's health or the far-end of toe;

A heater that is positioned at tubular sleeve, this heater are used for the described finger of measured's health or toe far-end are heated to predetermined temperature, thereby the arteries at described finger or toe place is at utmost expanded;

16. as 15 a described equipment, wherein said sleeve pipe also comprises a pressure applicator, this pressure applicator is used for applying a static pressure field of force around the far-end of finger or toe, the pressure of this pressure field enough prevents the alluvial of venous blood, and can when finger or toe and heart are in same horizontal level, partly eliminate the tension force of finger or toe place arterial wall, but obstructing arterial not.

17. as 15 or 16 described equipment, wherein said measuring device is measured is the change in volume corresponding to the blood pressure ripple at the distal portions of finger or toe.

18. as 15 or 16 described equipment, wherein said measuring device is measured is that the optical density (OD) corresponding to the blood pressure ripple at the distal portions of finger or toe changes.

19. be used for detecting the poverty-stricken equipment of measured's cardiopulmonary, comprise:

A pressurized source, when described tubular sleeve is admitted the far-end of the finger that has on measured's health or toe, this pressurized source applies the static pressure field of force around the far-end of described finger or toe, this static pressure field of force is enough to prevent to point or the venous blood alluvial of the far-end of toe, and when finger or toe and heart are on same horizontal plane, this static pressure field of force is enough to the tension force that part is eliminated this place's arterial wall, but obstructing arterial not;

20. be used for monitoring the dormant equipment of measured, comprise:

A pressurized source, when described tubular sleeve is admitted the far-end that finger or toe are arranged, this pressurized source applies the static pressure field of force around the far-end of described finger or toe, this static pressure field of force is enough to prevent to point or the venous blood alluvial at toe place, and when finger or toe and heart are on same horizontal plane, this static pressure field of force is enough to the tension force that part is eliminated this place's arterial wall, but obstructing arterial not;

21. as 19 or 20 described equipment, wherein said measuring device is measured is the change in volume corresponding to the blood pressure ripple at the outboard end of finger or toe.

22. as 19 or 20 described equipment, wherein said measuring device is measured is that the optical density (OD) corresponding to the blood pressure ripple at the outboard end of finger or toe changes.

23. as 19 or 20 a described equipment, wherein said pressure applicator applied pressure scope is 30mmHg to 70mmHg.

24. as 19 or 20 described equipment, the static pressure field of force that wherein said pressure applicator applies around the far-end of finger or toe from the position of measuring described variation with towards the direction of heart proximal extension one preset distance toward finger or toe.

25. as 19 or 20 a described equipment, wherein said pressure applicator comprises an overcoat, this overcoat has an installation deformable tubular film within it, this tubular film limits an outside tubular cavity with overcoat, and described tubular sleeve is used for admitting the measured to point or the described far-end of toe;

26. as 25 described equipment, wherein said deformable tubular film is divided into two parts of the radially relative both sides that are positioned at the measured's finger admitted in this place or toe.

27. as 25 a described equipment, wherein said overcoat is divided into a plurality of parts, connect together with each described membrane portions separately, and limit described outside tubular cavity with described membrane portions, each described membrane portions formation has four lateral films, and the neighboring of the overcoat part that this film is corresponding with it in its neighboring is fixed together.

28. as 25 a described equipment, the containment rod that wherein said tubular film is mounted on the coat is divided into a plurality of parts, this containment rod has the mid portion that is contained in the tubular film, thereby when the inside axially-movable of outer periphery that when described outside tubular cavity applies described pressure, can contain each membrane portions.

DETAILED DESCRIPTION OF THE PREFERRED

The detection of myocardial ischemia

The advantage of particular importance of the present invention is can not have wound ground to detect the poverty-stricken existence of cardiopulmonary.Therefore, below to the discussion of method and apparatus of the present invention and relate generally to the detection myocardial ischemia for example.But should be understood that reaction that the present invention can be used for detecting other health is embodied in physiological status and the health status on the peripheral arterial tonicity.Will be after discussion is crossed to myocardial ischemia for the example of some this respects.

In order more fully to investigate the favorable characteristics of method and apparatus of the present invention, here spontaneous (instability) myocardial ischemia is carried out a bit explaining.Outbreak to such myocardial ischemia for a long time has two kinds of viewpoints at least.According to Gorlin described (circulation 32:138,1965), its appearance is because the unexpected rising of blood pressure has induced the burden of heart to increase, thereby causes that the ischemia relevant with demand increases.According to Chierchia described (circulation 61:759,1980), the spontaneous outbreak of ischemia is a former incident, and when existing, they are caused by myocardial ischemia when some cardio-pulmonary function changes (for example heart rate, blood pressure, ECG change etc.).

The data (inventor is referred to as ischemia recording instrument Ischemograph) that adopt device of the present invention to obtain by the inventor show, bring out ischemia in case for example adopt expansible air bag in PTCA, and peripheral blood vessel shrinks to become and occurs within second at 10-20.(inventor adopted the drag measurement meter to see in the past, and increasing also of SVR can detect in these cases).Can see that the appearance that peripheral blood vessel shrinks manifests early than the signal of any cardiac systolic function variation adopting device of the present invention to monitor that ultrasoundcardiogram is traced in the exercise test equally.

The inventor can influence the new possible explanation of peripheral arterial tonicity proposition rapidly with having the development of theoretical knowledge to myocardial ischemia now.At first be because of the direct stimulation of active orthosympathetic activity to the periphery arterial tone.Another kind of possible explanation is to have discharged some factors when myocardial ischemia, as thromboxane (referring to Teoh, J.Thorac cardiovascular surgery 93:120,1987).Is also having a kind of being interpreted as because the local medium of vascular tonicity, because the borne enzyme agent of one or more endotheliums, for example endothelin-1 (endothelium-1?).

Therefore, in case myocardial ischemia begins, its development can injure patient.Reactive peripheral blood vessel shrinks and causes SVR to raise, thereby makes hypertension.Description according to Gorlin, hypertension increases the weight of the ischemia relevant with demand, cause left ventricular diastolic function unusual, and then contractile function is unusual, cause cardiac output to reduce, destroyed the balance of SVR formula so again, and then increased the weight of the peripheral blood vessel contraction, final result is by the persistent period of ischemia and the range size decision of muscle damage.

According to the present invention, the outbreak of myocardial ischemia can utilize the variation of measuring the peripheral blood vessel contraction to detect.The inventor also confirms, can measure peripheral blood vessel by the variation that detects the peripheral arterial intravascular volume and shrink.For example, can monitor the value of arterial pulse wave of patient's single finger (or toe).Like this, a unit in the arterial pulse wave value of this finger (or toe) can represent a unit of the tremulous pulse blood volume of the existence that the expression peripheral blood vessel of this finger (or toe) shrinks, and therefore the increase of Peripheral resistance means that SVR increases.

SVR one speech refers to the chamber resistance of the blood vessel of whole system to blood flow, and its size is by blood pressure (be actually arterial pressure and deduct venous pressure) and kinemic ratio decision.The SVR that calculates has provided whole resistance sums of this moment whole system situation when heart penetrates blood.

On the other hand, Peripheral resistance (PR) refers in body extremity, for example skin or other body surface, or refer to (toe) end, the resistance of locating as finger or toe etc.Peripheral resistance can show differently with SVR ten minutes, and for example a man is engaged in heavy physical labour under perishing environment, and he can have higher relatively skin Peripheral resistance value, but the resistance in the muscle of motion unload can be very low.Therefore, when detecting myocardial ischemia, when the increase of generally shrinking with peripheral blood vessel as SVR raises, vasoconstrictive direct measurement may be the parameter more responsive than SVR to periphery.In addition, SVR also may change with the change of cardiac output.

Device of the present invention can be used for monitoring the pulsation change in volume in the arterial vessel structure of finger, and has been proved to be and can detects peripheral blood vessel effectively and shrink.Under vasoconstrictive extreme case, detect by this device, represent health can have a down dip the basic straight line that is to a kind of pulse wave crest of reaction of physiological event to the size (amplitude) of trough.When in PTCA, adopting this device to monitor periphery response to main airbag inflation coronarius, particularly when not providing nitroglycerine to patient, this device can determine that blood volume reduces really in tested arterial vessel structure, and this shows that arterial tone and peripheral blood vessel contraction have increased.

Therefore, device of the present invention can directly detect the change of form in peripheral circulation, and this change partly becomes the basis that disclosed drag measurement meter is determined in the patent by people such as above-mentioned Goor SVR changes.Furtherly, when myocardial ischemia existed, drag measurement was counted and is measured SVR traumaticly, and the peripheral blood vessel contraction is directly measured on device non-invasive of the present invention ground.

The preferred embodiment of device

Device of the present invention consists essentially of a novel finger detecting head and one and is used for control survey process and collection and handle the Signal Processing system of finger detecting head.To comprise that their preferred embodiment is described to some embodiment of finger detecting head and processing system below.

Figure 1 shows that a finger detecting head 2 that constitutes according to one embodiment of the present of invention.Finger detecting head 2 comprises an inflexible jacket tube 3, and the diameter of this overcoat is more bigger than people's finger.One end of overcoat 3 is sealed by an end wall 3a, and the other end is an opening, and this opening is used for admitting people's finger.There is the deformable film (or capsule) 4 of a tubular configuration to be positioned at

overcoat

3, and 4a sealing at one end similarly, at relative other end 4b opening.Tubular film can be an elastomeric material, or is thin soft plastics layer material, and similar to a finger of rubber gloves basically.The hole that diameter limited by it is used for admitting an end of finger, and forms the tubular cavity 5 of a sealing between the inner surface of film and overcoat 3, and the expansion in this chamber and contraction are by the decision of the pressure in the chamber 5.

The opening 4b sealing and fixing of tubular film 4 is on the opening 3b of overcoat 3.The blind end 4a of tubular film can adopt any appropriate mode to be fixed on the blind end 3a of overcoat submissively, thus stop tubular film to the overcoat outer shaft to moving, but can not in overcoat, move.Fig. 1 a show adopt many flexibilities but not extending line 6 stop tubular film to the overcoat outer shaft to moving the example that also stops it in overcoat, to move simultaneously.Yet also can adopt other proper device to reach same effect, will provide further example below.

Chamber 5 between overcoat 3 and tubular film 4 links to each other with compressed air source or other fluid source that is formed on overcoat end wall 3a place by a port 7, and port 7 is connected with a pipe 7a.In order to obtain the measured value of tremulous pulse blood volume, will point the far-end that detecting head 2 is applied to finger (or toe), i.e. the far-end of the finger of measured's hands (or toe of measured's foot), and around finger (or toe) far-end, apply the static pressure field of force.

As mentioned above, prevent that venous congestion from being outstanding feature of the present invention.The inventor is definite, and under normal circumstances, venous blood is not controlled, and the mobile and alluvial at the finger pad place of unexpected ground.Therefore, the measurement that any desire changes volume/pressure will be subjected to the influence of the signal that produced by venous congestion, and this signal can suppress the required signal that is produced by the arterial pressure Reeb and/or make it to produce deviation, seriously disturbs actual measurement.An influence that key factor is the vein shock wave in the venous congestion, this factor is not noted in the prior art substantially.For example in exercise stress test, the venous lumen (large vein is carried blood to right atrium) of low-pressure has been shaken in the motion of health, produces shock wave, and this shock wave arrives finger tip with all approach back propagations.

Another causes that the reason of venous congestion is the rising of the static pressure of intravenous blood post.The result that this phenomenon for example produces in the arm lower end is the venous congestion that venous blood translates into finger.The result that volume shifts in the vein vascular structure of low-pressure is that the venous congestion in finger produces the signal useless to actual measurement, thereby has covered required information.

Therefore, the static pressure field of force that is applied preferably is enough to stop the end generation venous blood referring to (or toe) to deposit, but allows to be returned by vein by the pulsation blood that tremulous pulse is carried.In other words, pressure should be large enough to stop venous blood for example because static pressure and shock wave and from main flow, the blood that allows vein that tremulous pulse is carried simultaneously again transports out finger.Stop the required pressure of venous congestion to vary with each individual.But it preferably should not surpass more than 10% of this people's diastolic pressure.

In order to obtain signal more clearly, when finger (or toe) during near the heart level position, this pressure should be enough to part and eliminate the tension force that finger (or toe) is located arterial wall, but obstructing arterial not.Allow arterial wall to carry pulsation blood and freely-movable like this with heart.Preferably institute's applied pressure should be slightly larger than intravenous maximum pressure when hands is in lower fully.

Although convenient pressure can vary with each individual, can be suitable for above-mentioned all measured from 30mmHg to the pressure that is higher than in diastolic pressure 10% scope.Confirm clinically, when hands is on the minimum position of centrifugal dirty horizontal level, can find that the maximum vein pressure on the finger of tall person's Ziren is about 70mmHg.Therefore this pressure can be enough to remedy venous pressure under any circumstance, and can keep the VC of being on close level with the blood throughput of tremulous pulse in checking process effectively, impels vein to become the passive conduit different with the volume reservoir effectively.

As below will be in greater detail, finger detecting head 2 be to be used for measuring the change in volume (as the function of time) that produces corresponding to the blood pressure ripple in the finger that is monitored (or toe) end.This measurement to change in volume treated then (as will be described) is to detect or to monitor measured's physiological status or physique situation.

Fig. 2-4 is depicted as other embodiment that the present invention points detecting head.For convenience of explanation, those elements identical with the element of finger in the detecting head among above-mentioned Fig. 1 adopt identical numeral in Fig. 2-4.

The key character of the finger measuring probe structure shown in Fig. 2-4 is that it comprises the end cover of a sleeve-shaped, and this end cover constitutes a plurality of parts.Shown in Fig. 2 a and 2b, each in two

semi-cylindrical parts

31,32 forms a chamber, and these chambeies are common to form the [of the finger that is used for admitting the measured.Each

semi-cylindrical part

31,32 at one end forms part end wall 31a, the 32a of part circular or oval configuration, and they form circular or oval-shaped end wall together.The relative other end of above-mentioned each part is an opening.

Each

overcoat part

31,32 comprises the

deformable film

33,34 of a plane, and these films are configured to the equivalent of deformable tubulose film jointly, so that admit measured's finger.Each

film

33,34 is essentially the configuration of four sides, and the widthwise edge of end wall 31a, the 32a of edge overcoat part separately, the edge is the relative widthwise edge of the opening 30b of part separately, and (for example adopting glue or welding) fixed in two vertical limits of the side 30c of part separately in the edge.Two

overcoat parts

31,32 can adopt glue or other suitable manner to be fixed together, and (Fig. 2 a).

Like this, film 33 and its overcoat part 31 define an extendible chamber 35 together, and there is an import 35a in this chamber, and (Fig. 2 a); Film 34 and its overcoat part 32 define an extendible chamber 36 together, and there is an import 36a in this chamber.Two

import

35a, 36a are connected (Fig. 9) with pressure source 10 together by conduit 37.

Be essentially annular another chamber 43 and limited by

film

33 and 34 parts, this chamber extends to opening 30b from side 30c.This chamber 43 can be communicated with fluid between

chamber

35 and 36, and can be by

import

35a and 36a pressurization.As selection, chamber 43 can seal fully with

chamber

35 and 36, and independently by import 44 pressurizations.

In the single part configuration of finger detecting head shown in Figure 1, the axial force that causes by the pressure in the chamber 5 and power and the detecting head that produces are desired with respect to measured's finger and the tendency of axially-movable is suppressed by the elastica that is provided 6 thus.Can prevent that like this detecting head from coming off, and will reduce to minimum with respect to anthropic factor and the false readings that the axially-movable of pointing causes, particularly when the measured is in the rapid movement process, for example when taking exercises owing to detecting head.

On the other hand, such according to the embodiment that Fig. 2 a and 2b give an example, a plurality of part configurations of finger detecting head 30 make it to be fixed on tightly on measured's the finger and prevent axially and radial motion.This is because two films 33, the outer periphery of each is by

film overcoat part

31,32 fixed thereon in 34, thereby prevented to intrinsic displacement, the pressure by the intracavity of membrane closure moves inward the central area of each film like this, and the degree that moves is greater than its outer periphery.Therefore, the central area that moves inward of two films produces the clamping action in two zones in the relative both sides of measured's finger.This fastening clamp effect has reduced the possibility that detecting head comes off significantly, and can prevent that finger from rotating with respect to overcoat, prevent that finger is crooked, improved the certainty of measurement that the finger volume is changed with the blood pressure ripple, particularly when motion, can stablize the signal of outside output.

In the embodiment shown in fig. 1, the end effect that is caused by the opening of film 4 can reduce the precision of signal, this mainly be because pressure field can along it opening edge and die down.Therefore wish that film 4 can avoid this end effect.This point can add crimp and realizes by add one on the detecting head 2 at finger.This add crimp as the embodiment of back illustrates can with overcoat 3 for one or for isolating.In the embodiment shown in Fig. 2 a, pressurizing chamber 43 can be isolated at peripheral 30c place and chamber 35,36.Adopt this structure, the boundary effect of opening 30b will influence the pressure in the chamber 43 and not influence chamber 35,36.Therefore can only measure, to avoid boundary effect to

chamber

35,36.

As can finding out, reduce towards the opening 30b of finger detecting head by the beneficial effect of

chamber

35 and 36 applied pressures from above.Therefore, pressure field is owing to comprised and add crimp and extend beyond the measuring position effectively.

According to another embodiment of the present invention, the chamber 43 shown in Fig. 2 a is made of jointly overcoat part 31,32.This embodiment is illustrated among Fig. 3 a and the 3b for example, and wherein Fig. 3 b is the profile that A '-A ' cuts open along the line among Fig. 3 a.Shown in Fig. 3 a and 3b, be configured to rigid cylinder 41 for the columniform crimp 40 that adds substantially, film 42 is attached thereto.Space between film 42 and the cylinder 41 forms a chamber 43, and this chamber can be by import 44 pressurizations.Add the open end that crimp 40 can be fixed to the end cover that is formed by overcoat

part

31 and 32 shown in Fig. 4 a.This point is shown in Fig. 4 b.

Fig. 3 a, 3b and Fig. 4 b also show a pipeline holder 65.The pipeline holder can prevent the noise that produces that moves owing to pipeline effectively.Be preferably among all embodiment that the present invention points detecting head and all adopt the pipeline holder.

Fig. 5 shows another embodiment that annular adds crimp 40.According to this embodiment, adding crimp is many parts structure, is similar to many parts structure of pressure cowling among Fig. 2 a and the 2b.That is to say that if the structure shown in Fig. 2 a is isolated at peripheral 30c place, its result then is similar to and adds crimp.Like this, annular shown in Figure 5 adds crimp 50 by half-cylindrical part 51a two outsides, inflexible, and 51b forms, each part comprises a deformable film 52a who is separately fixed at the inside on the appropriate section, 52b, thus two semiorbicular

expandable cavity

53a, 53b limited at this.

Figure 6 shows that annular adds another embodiment of crimp.According to this embodiment, circumferential band 60 comprises one by flexibility, not extending material, external rings 61 and a cylindrical membrane fixed thereon 62 as not extending plastics are made come measured's finger is exerted pressure thereby limit an annular chamber 63.

Fig. 6 a-6e shows some embodiment, makes measurement not need air bag after wherein employing adds crimp.Shown in Fig. 6 a, the finger detecting head consists essentially of an end cover 30, and this end cover is provided with one and adds crimp 40.Shown in Fig. 6 c, when finger was inserted in the finger detecting head 2, chamber C0 was limited by overcoat and finger.Conduit 44a is used for to chamber 43 pressurizations that add crimp 40 qualifications, thereby obtains fastening sealing.Allow like this pressure to be sent among the C0 of chamber by conduit 37.

Shown in Fig. 6 b, the two halves structure of describing in detail above can adopting equally.In addition, bond layer preferably is provided or encircles 90 and suppress moving of detecting head, and increase air-tightness.On the inner surface of the tip of end cover 30 an adhesive material layer 91 is set, this helps to prevent to point detecting head with respect to finger motion more.

In addition, can guarantee airtight by the circumferential opening flange that a submissive membrane material 95 is set.The diameter of film upper shed should be less than that insertion finger of diameter minimum, and when the finger insertion, film can provide sealing like this.Can one less flange 96 be set at the opposite side that adds crimp.

Fig. 7,7a and 7b show the detailed structure of detecting head in the preferred embodiment of the present invention, and wherein pressure cowling and annular add crimp and be merged into an integral unit, and total usefulness 70 is represented.Unit 70 comprises a single rigid pipe 71, and its end is by a hemispherical or 72 sealings of semielliptical shape end wall, and the opening of the other end 73 is used for admitting measured's finger.Deformable tubular film 74 is contained in the jacket tube 71.Film 74 is 75 sealings at one end similarly, and in the opposite end 76 openings to admit measured's finger.

Jacket tube 71 is also admitted the rigidity containment rod that a U-shaped is arranged, and this rod represents that with 80 it has a pair of

parallel arms

81,82 that is linked together by semicircular mid portion 83.The

outer end

84,85 of two

parallel arms

81,82 is fixed in the

insert

86,87, and is fastening in the wall of rigid pipe 71.Two inserts 86,87 add pressure zone 88 supports by a circle that is fixed in the device, and respectively to the mid portion pressurization of tubular film 74, make it paste the inner surface of jacket tube 71 tightly.The opening 76 of tubular film 74 for example adopts glue or other to add on the opening 73 that pressure zone is fixed to jacket tube 74.

Can see, this structure qualification three chambeies: two chamber C1, C2 are positioned at the relative both sides of U-shaped containment rod 80 between tubular film 74 and jacket tube 71; And the 3rd chamber C3 of loop configuration is between the opening that adds pressure zone 88 and tubular film 74 and rigidity overcoat 71.Exert pressure by the wall that is pasting overcoat 71, around be with 88 can prevent that fluid is communicated with between the 3rd chamber C3 and two chamber C1, the C2.On the other hand, semicircle mid portion 83 inner surfacies best and overcoat end wall 72 of containment rod 80 are spaced apart, thereby at two chamber C1, provide direct fluid to be communicated with between the C2.Can be formed with one or two hole 77 on the overcoat 71, this hole is as chamber C1, the fluid inlet of C2, and another hole 78 is then as the fluid inlet of chamber C3.But it should be noted that if at chamber C3 and chamber C1, do not isolate between the C2, then electromagnetic valve 46 (back will be described) can save.

Can see, when at chamber C1, when applying fluid pressure on the C2, will be suppressed and can not move inward by each the outer periphery in the two parts of containing rod 80 tubular films that are bonded together 74.Like this, pressure fluid in the chamber C1, C2 will make the zone line of each membrane portions move inward, and it moves the mobile degree of degree greater than the outer periphery of corresponding respectively membrane portions, thereby produce 2 clamping actions, the axial and radial motion that stops finger to beat with respect to device and point.The part that is not covered by containment rod 80 of tubular film 74 limits an annular chamber C3, and it will be created in the above-mentioned identical circumferential band of describing in the discussion of crimp 40 of type that adds about annular.

Fig. 7, the advantage of the device shown in 7a and the 7b is that it is moving of causing that containment rod 80 has reduced the people, because if finger is with respect to installing motion, then at two chamber C1, the membranous wall of the membrane portions between the C2 is also consistent thereupon to move.Like this, when membrane portions adhered to each self-corresponding overcoat and partly goes up with glue respectively as described in top Fig. 2 a and the 2b, the motion of a diaphragm portion can not be sent on other diaphragm portion, has therefore produced this anthropic factor of motion.On the contrary, when two membranous parts were divided into same film shown in Figure 7 a part of, they trended towards moving together, and therefore having reduced this people is the motion that causes.

Another advantage of structure shown in Figure 7 is, enough to two chamber C1, C2 provides fluid pressure to single fluid inlet, and this is because the space that is provided by the containment rod makes their inner linking to each other.In addition, structure shown in Figure 7 is easy to produce change in volume, and low price.

Although do not illustrate, should be very clear, pipeline holder 65 also can be used among the embodiment shown in Figure 7.The pipeline holder can be fixed on the shell of detecting head, or is the part one of in the

insert

86,87.

Figure 8 shows that to be merged into that a usefulness 90 represents the finger detecting head of the glove that have on by the measured.Shown in structure in, two fingers of glove are equipped with detecting head, represent with 91 and 92 respectively.The 3rd glove refer to that 93 can be used to support the fluid hose to each chamber pressurization of volume measurement device, for example air hose.Glove can also be only on one or two refers to detecting head to be installed, and adopt bandage to be attached to measured's hands or wrist simultaneously.

The advantage of glove construction shown in Figure 8 is, it can allow detecting head is applied on two (or a plurality of) fingers simultaneously easily, can handle two-way (or multichannel) output signal like this handles, thereby obtain more useful consequence, for example in density is checked, select higher output or general output.On the other hand, each detecting head can be used for different measurements.For example, a detecting head can be used for the monitoring peripheral vasoconstriction, and another is used for monitoring patient's blood pressure.Measure Peripheral resistance and a clearly comparable whole hematodinamics state and the hemodynamics variation information that obtains more relevant patient of only measuring in these parameters of blood pressure simultaneously.

In addition, glove construction helps to stablize pipe, prevents to be transferred on the volume measurement device owing to dragging the power that pipe produces.Particularly, except at detecting head from increasing on one's body the pipeline holder 65, (Fig. 8 a), wherein split ring is placed on the finger that does not have detecting head also can to add a pipeline holder 65a on a split ring 66.Very clear, pipeline holder 65a and split ring 66 can independently be used for glove embodiment.

Glove (or any finger detecting head) can be installed heating element heater selectively and add a whole hands.The position that adds thermal measurement can be used for changing the basic degree of vascular tonicity.Can allow like this vascular tonicity is set to certain a bit, can measure preferably in the place oneself control of body of this point, because the high-caliber vasoconstriction that is pre-existing in can hinder the further measurement that vasoconstriction is increased.

Fig. 9 shows the preferred embodiment that the present invention is used for detecting the device of myocardial ischemia.The inventor is referred to as the ischemia recording instrument with the device of this structure, traces processing (IschemoGraphy) and the processing of this invention is referred to as ischemia.

As shown in Figure 9, finger detecting head 2 comprise sleeve-shaped end cover 30 with link to each other with pneumatic system that total usefulness 80 is represented add crimp 40, pneumatic system links to each other with the processing system that total usefulness 90 is represented again.Pneumatic system 80 consists essentially of the pressurized source 10 that a pneumatic tube systems of representing with total usefulness 85 links to each other.Tubing comprises pressure is transported to the finger pipe 7a of detecting

head

2 and 44a and can be by the

electromagnetic valve

12 and 46 of processor 23 controls described later from pressurized source.Certainly, electromagnetic valve 12 and the 46 replaceable mechanical valve that become manually to control.

Pneumatic system 80 comprises that also is used for monitoring a pressure transducer 13 and the pressure-gradient transducer 14 by the pressure of source 10 supplies, and this differential pressure pickup is used for measuring the pressure that changes in the finger detection cavity and is present in difference between the constant pressure between valve 12 and 46.Selectively, pneumatic tube systems 85 also is provided with

reservoir

47,48 and 49, dots reservoir among Fig. 9, means that it is optional equipment.Can be provided with one or arbitrarily a plurality of this additional reservoirs reduce at corresponding intracavity owing to leak or the sensitivity of the change in volume that little gas volume loss that the elasticity of corresponding tubing causes is caused, and reduced the change of the back pressure scope that causes owing to pulse wave.

In Fig. 9, on the line that the pipeline with pressurized source and pneumatic system 80 is connected together, there is not valve.This is that pressurized source comprises inner valve because in a preferred embodiment.But,, then be preferably in the outlet of pressurized source 10 and add a valve if there is not this inner valve.

Processing system 90 comprises 22, one processors 23 of an A/D converter and a monitoring arrangement, and this monitoring arrangement generally is expressed as monitor 24 and siren 25.Processing system is responsible for controlling the operation to whole system, as control pressurized source 10 and

electromagnetic valve

12 and 46, and also handles detected signal, thereby decipherable output is provided.

As from can finding out the above-mentioned explanation, it is poverty-stricken that device of the present invention can be used to detect cardiopulmonary under various environment, particularly detects myocardial ischemia.In other words, this device can be used in exercise test monitoring that it can be used for monitoring, and can be used for monitoring sleep in balloon angioplasty.And in all cases, the basic operation of this system is the same.

Below with reference to Fig. 9 the operation of system is described.In order to carry out a diagnotor, at

first valve

12 and 46 is opened, the

chamber

5 and 43 aerofluxuss of finger detecting head, thus allow patient that its finger is inserted in the detecting head.Then, pressure is elevated to is enough to make arterial wall not to be subjected to load, and can prevent venous congestion.Can measure by pressure transducer 13 by pressurized source 10 applied pressures in the upstream of valve 12 and 46.In a preferred embodiment, the pressure in pneumatic compartment is elevated to 70mmHg automatically.

At this moment,

valve

12 and 46 closures, the pressure in the right-side cavity of pressure-gradient transducer 14 keeps constant like this.On the contrary, the pressure of transducer 14 left side intracavity is with the change in pressure in the chamber 5 of finger detecting head 2.Especially, device of the present invention detects when peripheral blood vessel shrinks and needn't calibrate, and compares because this measurement is a baseline with the patient who obtains in process of the test oneself.

In order to obtain a good result, be necessary in test to make palmistry to fixing.In various exercise stress tests, this point is generally by remaining on hands on the stable position and avoiding hands excessively to move and realize.Fixing general being out of question in PCTA or sleep supervision, this device is used for monitoring ischemia in the obstruction process herein, and monitors the obvious expansion of tremulous pulse afterwards.

Can find out further that from above-mentioned explanation the variation that the measured who produces owing to the arteriotony pulse wave points volume makes chamber 5 expansions or shrinks, thereby makes the gas pressures in the chamber 5 reduce or increase.As mentioned above, chamber 5 links to each other with pneumatic tube systems 85 with pipeline 7a by its import 7.But, owing to valve 12 cuts out, so the variation of pressure only influences the pressure of pressure-gradient transducer 14 left side intracavity.Pressure-gradient transducer 14 detects the variation of these pressure, and provides an output corresponding to the variation of pressure.

A/D converter 22 shown in Figure 9 receives the simulation output of

pressure transducer

13 and 14, and converts digital quantity to before transferring them to CPU processor 23.The finger volume (or optical density (OD)) that 23 pairs of processors measure changes to be handled, and produces the output 24a of cubing and/or the output 24b that cubing changed with respect to the time.One or two measurement result can be presented on the monitor 24 (for example CRT or LCD).In addition, these outputs can be presented on the monitor separately.Furtherly, these measurement results can be transmitted and be shown to far place, for example nurse's monitoring station.

If the output 24b that shows shows that the change in volume that measures has exceeded predetermined cut-point (cut-off point), illustrate that then peripheral blood vessel shrinks, this point observer will see immediately from observing on the monitor 24.Selectively, if this predetermined variable quantity occurred in measurement volumes, then siren 25 (for example by sound or vision) action is pointed out immediately.

The ratio that is varied to of signal wave crest and arterial pulse volume general to the amplitude of trough, and will shrink and descend with peripheral blood vessel.Therefore, when adopting system shown in Figure 9 to detect the peripheral blood vessel contraction, the observer will be interested in to the variation of amplitude between the peak value valley, rather than interested in the absolute value of pressure.So, in a preferred embodiment, adopt high pass filter 28 to come filtering is carried out in the output of pick off 14, thereby improve the signal to noise ratio of signal.

As the description that above-mentioned adversary refers to detector, the finger detecting head preferably includes an annular coaxial and adjacent with it with end cover and adds crimp 40, and this adds nearly (heart) side that crimp is positioned at device.The main purpose that adds crimp is that the border with the constant pressure field extends to beyond the limit that exceeds the sensor measuring head, can avoid boundary effect like this.Add in the chamber 43 of crimp and also be filled with gas-pressurized by import 44; But electromagnetic valve 46 makes transducer 14 isolated with conduit 44.Like this, hoop 40 is extending certain distance with the measuring position beginning that the blood pressure ripple changes towards the direction of near-end (heart) from the finger volume with the static pressure field of force.Annular adds crimp 40 and plays the tourniquet effect with the pressure field that produces in sleeve-shaped end cover 30, prevents far-end (the particularly phalanges of distal-most end or the phalanx place) alluvial of venous blood at finger (or toe).It can also prevent uncontrolled venous return basically; And especially, it can unload the tension force of finger tips arterial wall on same horizontal plane the time with heart at finger.Pressure in adding crimp and induction cavity 35,36 not simultaneously, it should not surpass cavity pressure.

Figure 10 shows the hand-operated pneumatic control system that can be used for replacing automatic pressurized source 10, and this system is used for presetting and apply the static pressure field of force to the end cover 30 and the tubulose hoop 40 of finger detecting head.System shown in Figure 10 comprises one four the tunnel, presets valve module 150 by what screw was installed, and four of having four common cavity by valve module to derive of this assembly import and export 151-154.Import and export 151 and link to each other with a reservoir 161, this reservoir links to each other with a tubulose hoop 140 again; Import and export 152 and link to each other with second reservoir 162, this reservoir links to each other with pressure cowling 130 again; Importing and exporting 153 links to each other with the 3rd reservoir 163; Importing and exporting 154 links to each other with relief valve 165 that atmosphere communicates with one with a syringe 164.Pressure-gradient transducer 166 is corresponding with the transducer 14 among Fig. 9, and it links to each other with 163 with reservoir 162, and compares the pressure reduction between them.Transducer 166 also replaces the piezometer 167 of the transducer 13 among Fig. 9 to link to each other with one.The output of transducer 166 offers processing system in the mode similar to Fig. 9.

System shown in Figure 10 operates as follows:

At first, open and preset valve module 150, all are imported and exported between the 151-154 be communicated with.Open relief valve 165 then, this system is linked to each other with atmosphere.Syringe is extracted to the centre position of its gamut; Close relief valve 165; Then syringe 164 is pulled out to maximum projecting position, thereby in the common cavity that presets valve module 150, produce vacuum.

To point then on the finger that detecting head is applied to the measured.Inwardly push away syringe, up to reaching predetermined pressure; Next close and preset valve module 150, the 166a that enters the mouth like this remains under the pressure constant state, and inlet 166b changes with the cavity pressure of pointing detecting head.Therefore, any pressure of being experienced by transducer 166 changes will be consistent with the arterial blood liquid measure, and corresponding signal is outputed in the processor 23 by transducer 166 and handles.

The present invention who describes in detail for example in the above points in the detector, and the peripheral arterial vasoconstriction is experienced by pneumatic mode, and promptly the pressure that is caused by the change of blood volume in the peripheral arterial by impression changes and experiences the peripheral arterial vasoconstriction.But should be understood that and also can measure the variation that takes place corresponding to changing at skin or other end of patient by the poverty-stricken peripheral arterial tonicity that causes of cardiopulmonary.For example, optical density (OD) or the surface reflectance of adopting a light source and optical receiver to measure finger (or toe) outboard end or other regional skin of human body.Determine the electric current that skin produces by measuring resistance; Adopt doppler ultrasound device or other flow rate measuring device can measure blood flow rate.

Equipment shown in Figure 11 similar to shown in Fig. 1-7, just this equipment pair is directly measured with the change that the blood pressure ripple is pointed optical density (OD) accordingly.For the ease of understanding, represent with identical reference marks with the corresponding part of Fig. 1-7.

Like this in equipment shown in Figure 11, chamber 5 as above-mentioned at pressurized being connected on the predetermined valve the description of Fig. 9.But in this case, side at the tubular diaphragm 4 that limits chamber 5 is provided with a light source 100, at opposite side an optical receiver 101 is arranged, the variation of the pulsation blood volume at the finger place of tubular diaphragm 4 admittances will be detected by optical receiver 101 by the variation of optical density (OD) like this.This information is sent in the amplifying circuit 103 by lead 102, and here this information is exaggerated filtering, and information is sent to A/D converter 22 then, is handled by above-described processor 23.

In layout shown in Figure 11, the opening of the rigidity overcoat 3 of detecting head 2 should be considered to be positioned in the measuring position that is called light source 100 and optical receiver position, wherein this detecting head evenly applies the static pressure field of force around the outboard end of finger, and the ring-type that does not therefore need to be used for this purpose here adds crimp (Fig. 9 40).But the position that makes light source and optical receiver if desired is near the opening of the rigidity overcoat of a little detecting heads 2, then also can adopt ring-type to add crimp (corresponding to adding crimp 40 among Fig. 9) in system shown in Figure 11.

In PTCA (balloon angioplasty), the part blood that cuts off wittingly cardiac muscle supplies one section known time.Under the condition that other situation do not occur, nobody can be well understood to interferential time of coronary blood flow, position and scope.Therefore in this operation process, estimate ischemia recording instrument of the present invention by a plurality of patients.

In theory, the effect that is used to block the swelling gasbag of coronary blood flow is subjected to certain restriction.For example, if one section coronarius gets clogged basically, the action itself of then inserting the conduit be used to transport air bag can have been dwindled the aperture of remainder widely, and the expansion by air bag comes further reaming footpath can not change blood flow as desired widely like this.Furtherly, at every turn to around the cardiac muscle pressurization can cause with expanded balloon and the irrelevant reflex response of blocking-up of coronary blood flow.

Although these factors can change the blood flow relevant with the effect of crown PTCA, the in question discovery in back can clearly illustrate to exist between the variation of Peripheral resistance and the myocardial ischemia and get in touch.

Figure 12 shows that to ischemia recording instrument output signal of the present invention before not carrying out carrying out airbag inflation in the patient's coronary artery at vasoactive Drug therapy, in the airbag inflation process and behind the airbag inflation about the process of time.Output and pulsation tremulous pulse change in volume, promptly consistent with the variation of amplitude accordingly of tremulous pulse change in volume from the signal trough to crest.Like this, crest to the minimizing of amplitude between the trough will mean vasoconstriction, and the increase of amplitude will mean vasodilation.The datum line that is used for comparison is set at and is exciting heart to increase the amplitude of the trough before the demand of oxygen to crest.

As shown in figure 12, air bag expands constantly about zero.Then, be carved between 1 minute from zero the time, signal wave crest subsequently to the amplitude of trough reduces continuously, this means that expansible air bag causes the peripheral blood vessel contractile response, thereby reduces temporary ischemia.

Rear gasbag venting in about 70 seconds, but reexpand after half a minute approximately.Venting in the relative short period fails to observe significant variation.In other words, the signal amplitude and the signal amplitude in 1 minute to 3 minutes that are carved in 1 minute from zero time of research can infer that the peripheral arterial tonicity increased gradually, kept relative stability then in about 1 minute process in 30 seconds.But should be appreciated that the response time of reference here comprises airbag inflation and used time of venting.

The moment 5 patient of place cough in Figure 12, the amplitude that can observe signal increases fast intensely.In some cases, this cough or yawning pressure wave can be propagated by tremulous pulse.This pressure wave can detect by IschemoGraph of the present invention, and can be by its rapid relatively rising and decline curve and very short differentiation of its persistent period.

The block diagram that the output signal that Figure 13 interrelates with airbag inflation in 67 PTCA processes for 29 patients of main expression changes.At each constantly, the variation of signal value is used as the reference value that shows that ischemia reduces in the airbag inflation process.The output signal of equipment shows: when 23 examples are taken nitroglycerin aorta is not carried out (with negative sign (-) expression) in the PTCA process, have 23 examples to have myocardial ischemia.(with positive sign (+) expression) has 7 to present positive reaction among 8 patients after taking nitroglycerin.Also show the result who takes and auxiliary coronary artery is implemented when not taking nitroglycerin PTCA among the figure.As predictable, ischemia not easy to identify in these cases.

Equipment shown in Figure 9 has been used for clinical research, the myocardial ischemia situation that this equipment is used to detect patient when carrying out the exercise test of standard, gained result with adopting existing thallium SPECT and ECG technology the result compare.

Sheba medical centre that Figure 14 shows in Israel and Kaplan hospital carry out adopts relation between thallium SPECT gained result and the employing ischemia recording instrument gained result of the present invention when 93 patients are done the standard movement stress test.Upper left square frame shows that thallium SPECT is defined as male whole patient (53) ischemia recording instrument and also is defined as the positive.(Figure 15 shows a patient's typical data, and this patient's thallium SPECT and ischemia recording instrument diagnostic result are all positive.) therefore the difference between two kinds of methods only be on the negative findings.

Further, shown in the lower right square frame among Figure 14, thallium SPECT judges to have 40 patients negative, and the ischemia recording instrument judges that also that 28 patients are arranged is negative.(Figure 16 shows a patient's typical data, and this patient's thallium SPECT and ischemia recording instrument diagnostic result are all negative.) shown in the upper right corner of Figure 14, remaining 12 patient's thallium SPECT diagnostic result is negative, and the diagnostic result of ischemia recording instrument is all positive.In these 12 patients, 3 patients' doctor advises that they carry out coronary angiography.All finding in all above-mentioned three kinds of cases needs coronary artery disease is carried out Drug therapy, thereby has affirmed the positive findings that the ischemia recording instrument draws.

In a word, the data that provide according to Figure 14, to adopting the ischemia recording instrument to compare with adopting thallium SPECT technology, diagnostic result is identical to be 87%, and for remaining 13% (12 patient), 3 patients have implemented coronary angiography further to study, and each example has all been affirmed the positive diagnosis result of ischemia recording instrument.

In contrast, Figure 17 shows that the known ECG technology of employing substitutes thallium SPECT technology is carried out the above-mentioned exercise stress test of mentioning to 93 patients result.The purpose of carrying out this comparison is to consider that ECG is considered to the conventional tool of the unique myocardial ischemia generally investigated, and it than thallium SEPCT simple cheap many.Figure 17 comprises triplex row, because some result that ECG provides is indeterminate and can not reaches a conclusion.As shown in the figure, 50% situation is only arranged is consistent with the result of thallium SPECT to the result of ECG.

Shown in upper left corner square frame among the figure, 20 patients among only that thallium SPECT is really positive 53 patients of ECG are defined as the positive.And, all think malely even ECG in left-hand line second row is designated as indefinite result, ECG still only is defined as male patient with 59% thallium SPECT and is judged as the positive.

Shown in the square frame of lower left among the figure, the ECG data are judged as feminine gender with 22 patients that thallium SPECG is defined as among male 53 patients.In other words, with result's comparison of thallium SPECT, ECG carries and shows 41% false negative.And, if 11 indefinite results in the row in the middle of the left-hand line are thought negative, then to compare with the positive findings of thallium SPECT, the error result percentage ratio of ECG rises to 62%.This is unallowable obviously because be defined as being in peril of one's life among the patient that situation exists by thallium SPECT, if having nearly half people only adopt the ECG method test the back defendant for healthy.

Relatively the result of Figure 14 can be clear that the superiority that new technique is compared with for example ECG technology with the result of Figure 17.Yet the present invention also has the many very important superior part above thallium SPECT technology (and other known technology): they are very simple, and the equipment that needs is very cheap, in testing process human body is not had injury, particularly can obtain result of the test rapidly.The last item advantage particular importance is because if after detecting the myocardial ischemia outbreak, it allows abort immediately, has reduced the life danger that patient emitted like this.

Figure 18 shows the advantage aspect some that the present invention embodied more significantly after having investigated 25 patients.According to the data among Figure 18, adopt novel method of the present invention correctly to detect used average time and traditional Bruce 40% (less than 6 minutes) of stress having tested 9 minutes used reduced in comparison.This is an important advantage, because it allows to finish as soon as possible test as mentioned above, thereby reduces dangerous.In addition, data demonstrate also that the average required pulse rate of technology of the present invention is lower than stress Bruce experiment 14%.So also reduced the danger that patient is emitted in test.It should be noted that at last because the Bruce experiment is a kind of test that increases load gradually, the final stage of test is the most dangerous, and adopts equipment of the present invention can avoid the appearance of final stage.

In the test of Miao Shuing, the decline of amplitude output signal usefulness is done the indication to myocardial ischemia in the period of motion in the above.The others of output signal time graph also can be used for providing valuable information.The example of a particular importance is relative size size and the shape that signal changes in motion later stage or restore cycle.Therefore, Figure 19 shows that the variation of amplitude output signal in motion and restore cycle, and Figure 20 shows that motion later stage maximum/minimum (D/C) and the comparison of the ratio (B/A) of minimum/maximum in motor process.

In these trials, in motor process, reduce to 0.82 or when lower (promptly having descended 18% or more) as ratio B/A, or indication myocardial ischemia when ratio D/C meets or exceeds 2.8 (promptly having raise 2.8 times or more) during restoration.Like this, figure shown in Figure 20 is divided into four quadrants by intersecting lens B/A=0.82 and D/C=2.8, and the patient who wherein falls into right lower quadrant is thought of as feminine gender.As can be seen from the above, the susceptiveness of system can change one or two intersecting lenses among removable like this Figure 20 by " cutting " value that changes ratio.It will also be appreciated that the motion end point relevant with patient age (relating to maximum heart rate) will influence the criterion value.

Obviously, above-described technology can be united use with the indication myocardial ischemia with of the prior art one or more, thereby improves whole result's accuracy.Particularly the present invention can be used to carry out initial screening simply, cheaply in doctor's office.The doctor can be by allowing patient carry out the test second time of other type or carrying out coronary angiography and confirm positive findings then.

Supervision to sleep state

As mentioned above, the invention has the advantages that can not having wound ground detects physiological status or health status.Although above-mentioned discussion focus mostly concentrates on the detection myocardial ischemia, adopt method and apparatus of the present invention also can detect other physiological function disorder.For example the inventor proves, and said method and equipment can be used to monitor measured's various sleep states, especially for detect rapid eye movement (REM) sleep period, sleep apnea syndrome (SAS) and night myocardial ischemia.

Clinical research

Equipment of the present invention has been in the sleep procedure patient to be tested.The REM incident is come out by device description of the present invention, and the crest that it is characterized by pulse wave to the amplitude of trough reduces.

Known in REM period, autonomic nerve is regulated multilated.The relation between but REM and peripheral blood vessel shrink is not also understood.It is relevant with REM clinically that the inventor thinks that peripheral blood vessel is contracted in, this is because sympathetic nerve is overexcited, if when perhaps having coronary artery disease since myocardial ischemia cause.

The outbreak of sleep apnea also can be noted by Ischemograph of the present invention.In these records, there are some records to show, exist contact between the pulse wave that oxygen saturation reduces gradually and Ischemograph monitors that is monitored by pulse oximeter reduces gradually.Because general hypoxemic result is the oxygen supply that has reduced cardiac muscle, like this, actual equivalent effect is because coronary artery disease or valvular heart disease have reduced the normal saturated blood confession to cardiac muscle.

Be known as " sleep scanning line (hypnogram) " shown in Figure 21 a and the 21c, show that the sleep period that comprises REM begins and continues.When adopting above-described present device to test measured in the sleep, can see in the REM phase and sleeping when occurring at every turn that the output signal of equipment all presents tangible abrupt change (seeing Figure 21 b).Topmost (thick line of Figure 21 in a) represented the REM phase to scanning line.The signal that it should be noted that REM and ischemia recording instrument temporal being closely connected between (seeing intermediary scanning line, Figure 21 b) that descend.

Shown in Figure 22ly lead sleep for the standard during non REM sleep, noted more and trace in the line one section.Therefrom as can be seen, each asphyxia appears at when the flow signals time slack that flattens.As shown in figure 22, when each asphyxia occurred, the output signal of ischemia recording instrument (being designated ISCH) was along with oxygen saturation (SaO ₂) time graph present multiple feature mode: raise circularly and reduce.

Like this, as shown in figure 22, the oxygen saturation that is monitored by pulse oximeter exists contact between reducing gradually and being reduced gradually by the output signal that equipment of the present invention produces.Because general hypoxemic result is the oxygen supply that has reduced cardiac muscle, like this, actual equivalent effect is because coronary artery disease or valvular heart disease have reduced the normal saturated blood confession to cardiac muscle.

Such as previously mentioned, method and apparatus of the present invention can be used for continuous non-invasive wound property blood pressure and monitors after carrying out some change and adopting novel calibration program.Generally speaking, the finger detecting head is used to detect the finger pulsation change in volume that is caused by the suction action of heart.In other words, can detect the suction action of heart by the arterial blood quantitative changeization of finger sensing place pulsation.

As mentioned above, adding press mold is used for applying at tested phalanges or phalanx place a static state and adds and have a meeting, an audience, etc. well under one's control.The result that consequential slight invasion to the arterial vessel structure (eliminating the tension force of wall) produces has amplified required pulse wave signal.And the present invention prevents that the feature of venous blood alluvial from having increased the precision and the intensity of blood pressure measurement, and the present invention simultaneously needn't consider actual used pick off, promptly responds to pick off that change in volume, optical density (OD) change etc.

To see that like this what common plethysmography was measured is the whole change in volume that is studied colony, the arterial rete channels kinetoplast of the finger part that is studied is long-pending to be changed and measurement of the present invention only relates to especially.

In existing finger plethysmography, finger detecting head or employing add the form of crimp, perhaps adopt and be installed in non-pressurized cover at finger tip place.The detecting head that is now adopted is different with it, and it adopts the pressure cowling form that contains whole finger tip.Traditional hood-shaped detecting head often exists when exerting pressure firmly releases tendency with finger tip in detecting head.On the other hand, also can exert pressure, but it can produce venous congestion at the end away from hoop even bind round when not extruding finger.Sleeve-shaped pressurization detecting head of the present invention has been avoided these drawbacks.At first, the best pressure with described band of the pressure in the cover mates, and can prevent the expansion of vein vascular structure like this.The second, adopt as plastic tape (Fig. 1), chamber isolation thing (Fig. 2) or containment rod (Fig. 7) and can avoid finger to be extruded.Film is deformable, therefore can adapt to the whole surface of finger tip, comprises the distal-most end of finger tip.

Shown in Figure 23 for be used for the finger detecting head 2a that continuous blood pressure is measured through modification.Should be noted that according to the description of back, any detecting head among Fig. 1-9 all can be revised.Especially, shown in Fig. 23, around the outer surface of overcoat 30, be provided with an electrons heat coil 8 that protects by outer insulative layer 8a,, preferably reach 38-40 ℃ so that the finger of the measured in

tubular film

33 and 34 is heated to predetermined temperature.Electro-hot regulator 9 control electric heaters on the overcoat inner surface are so that insulation makes the vasodilation at finger place like this.

Especially, in order to measure blood pressure, the interested absolute value that is pulse wave with respect to zero base line.As will be described later in detail, these values will be used to analyze the metrical pressure dependence of vessel volume of patients fingers.Therefore, its advantage is to eliminate or has avoided except that the heart suction other to influence the change in volume that is caused.For the influence of heart suction, finger is heated, thereby tremulous pulse is expanded to greatest extent, therefore can freely adapt to the variation that is caused by pulse wave, and the peripheral blood vessel that can eliminate the place, measuring position so effectively shrinks.In other words, the muscular tissue of tremulous pulse (vessel smooth muscle) is relaxing and make the resistance minimum to greatest extent, and the behavior of tremulous pulse is passive like this, shows not have initiatively to stretch.

As shown in figure 23, electrical heating coil 8 is by the power supply power supply of electric wire 16 by power supply circuits 15.Chamber 35 is adjusted to predetermined temperature 38-40 ℃ with 36 interior temperature by the controller 17 that links to each other with electro-hot regulator 9 by electric wire 18.

In addition since interested be the absolute value of signal, so remove the high pass filter among Figure 23.Can determine crest, trough and absolute value between the two like this.Yet, must consider that also (this point influences the calibration program really) and this difference value are very big with respect to the difference of the varying level position static pressure of heart for accurate blood pressure readings is provided.Concerning a male with average height, this difference is about 120mmHg.Therefore, equipment of the present invention also comprises that through modification novel being used for measure the device of static pressure horizontal level, adopts novel mode to calibrate equipment of the present invention then.

For this purpose, cubing equipment shown in Figure 23 comprises that also is used for the pick off 19 of finger sensing detecting head with respect to the upright position of reference point.This information is used to calibrate in the phase process, thereby will convert the measurement to blood pressure to the measurement of finger place change in volume to.Pick off 19 also is used for the general operational phase, thereby can be in the more accurate measurement of this place acquisition when measured's finger (or toe) changes its upright position change of occurrence positions (for example in the motion time) with respect to measured's heart.

At the embodiment for example that is used for shown in Figure 23, the form of upright position pick off 19 is the chamber of a full of liquid (preferably water), one end of this chamber is sealed by a softish film 19a, and links to each other with a pressure transducer 21 by water-filled pipe 20 in its opposite end.Like this, the electrical output signal of detecting head with respect to the horizontal level of measured's heart just pointed in the upright position that transducer 21 produces corresponding to water-filled overcoat 19.

As can seeing from above, can adopt the whole bag of tricks, comprise use or do not use pneumatic process to detect the tremulous pulse blood volume.Therefore, although system shown in Figure 23 employing is the variation that pneumatic process is responded to volume, this system also can adopt other pick off, light source 100/ optical receiver 101 as shown in figure 11.Be noted that equally adding crimp 40 can save, the replaceable one-tenth of detecting head has and similar membrane structure shown in Figure 1.

Equipment of the present invention is at first calibration before being used to measure blood pressure, thereby could convert the measured value of change in volume to pressure value.For this purpose, arms up and lower with correspondence for the measured, so that obtain the static pressure of symbol measured's finger with respect to the upright position of heart level position.When obtaining the variation of measured's finger place volume by the variation of measuring the expandable cavity internal pressure of pointing detecting head, this static pressure is superimposed upon on measured's the arterial pressure, and both combineds effect resist the counter-pressure (being preferably 70mmHg) that applies at first.

In the calibrating procedure incipient stage, open two

valves

12 and 46, two chambeies 35 of

cover

30 and 36 and the chamber 43 that adds crimp 40 be deflated.This allows the measured will point in the tubular film 43 that inserts hoop 40, and between the

film

33 and 34 of end cover 30.Three chamber inflations reach the initial pressure value then, are about 70mmHg, close with latter two valve 12 and 46.Next heater 8 energising is heated to temperature with measured's finger and reaches 38-40 ℃, and this temperature is kept by thermoregulator 9 and temperature controller 17.

As mentioned above like that, measured's finger is heated to the 38-40 ℃ of vasodilation that can make measured's finger place to greatest extent.The intravenous static pressure in measured finger place added the remaining venous pressure of about 15mmHg of the horizontal position venous pressure that representative is identical with heart when on behalf of hands, the pressure that is applied to the 70mmHg in three

chambeies

35,36,42 hang low fully, added additional safe clearance.

The measured raises hands with end cover 30 and hoop 40 gradually to the extreme higher position that is higher than the heart level face, gradually hands is lowered to the extreme lower position that is lower than the heart level face then, once more hands is raised to the extreme higher position that is higher than heart at last.Pick off 19 is sensed the upright position of end cover 30, and measures a finger of representing the measured in the output signal with respect to the static pressure of each upright position of heart by transducer 21.Be converted the variation of pressure in the

coelosis

35,36 with the continuous variation of the corresponding measured's finger of blood pressure ripple place pulsation volume, the variation of this pressure is recorded by transducer 14.

Transducer

21 and 14 can be exported its measured value by electric wire or by wireless telecommunications.Two

transducers

21 and 14 output convert digital signal to and send CPU23 to by A/D converter 22 to be handled.Static pressure is constantly deducted from fixed counter-pressure, thereby obtains effectively to exert pressure (Pappl), the value that the force value that Here it is when pointing endarterial pressure when mobile from it identical with the heart level position begins to change.

Hands raise and the process lowerd in, the voltage output of pulse signal also enters into CPU.The crest of each pulse wave (heart contraction), trough (diastole) point and be determined with their corresponding Pappl values.The analysis of cardiac shrinkage value and with their corresponding Pappl values this obtains being called the regression equation of cardiac systolic function curve to data.Similarly, analyze one group of diastolic value and obtain being known as relation between the diastolic value of cardiac diastolic function curve and the Pappl value correspondingly.

Test the diastolic function curve then and determine the no longer smooth point of part in latter stage of each one pulse wave.Latter stage part is no longer smooth to be because Pappl presses greater than internal arteries, and tremulous pulse is stressed and be crushed, and makes its volume fade to minimum.Here it is diastolic pressure.

In case patient's diastolic blood pressure is known, can accurately calculate effective arterial pressure of each horizontal position in the vertical displacement process of diastolic function on the diastolic blood pressure values that then static pressure is added to.If to lift when high the diastolic function curve fully constant smooth when arm, then continue the extra external pressure of stack, flatten smooth up to the diastolic function curve.

If systolic pressure is lower than external pressure, and arterial pressure reduces when arms up, then can calculate systolic pressure by the reproduction of determining pulse first signal when hands hangs low.If not this situation, 2 points that can equate by the tensor sum amount of contraction signal that determine to relax so, and measure the poor of static pressure between 2, calculate systolic pressure on the diastole value that then differential static pressure is added to.The position of preferably above-mentioned definite point surpasses diastolic function slightly and has passed through after the smooth phase.The pressure determined of general using and the functional relationship between the pulse signal voltage are calibrated pressure limit then, thereby convert pulse signal to pressure data.

Can know from top description and see that the present invention can prevent feature advantageous particularly in the calibration program of venous congestion.In other words, for appropriate calibration, the variation of pressure should be only corresponding with the variation of tremulous pulse volume.If do not prevent venous congestion, then blood can accumulate in the finger place, and pressure will be the function of tremulous pulse change in volume no longer only.

Be how equipment shown in Figure 23 is used for directly measuring the change in volume (as the function of time) of measured's finger corresponding to the fluctuation of blood pressure that is caused by measured's heart beating below, and this measurement converted to the explanation of blood pressure by above-described calibration program.

In order to measure the variation of finger volume, measured's finger inserted in the tubular sleeve that is limited by finger detecting head 2, end cover has been sealed the distal-most end that the measured points phalanges like this, covers on the adjacent phalanges shown in Fig. 4 b and bind round 40.Chamber pressurization then, electric heater 8 energisings will be pointed heating, make temperature reach about 38-40 ℃.Keep this temperature by temperature controller 17, the arteries at measured's finger place is expanded to greatest extent, thereby the resistance that can keep in measurement afterwards blood flow is minimum steady statue.It is constant that temperature controller can also make gas temperature keep.Film is forced into predetermined pressure by source 10, and this pressure is enough to prevent basically venous congestion and uncontrollable venous return, and can also partly eliminate the stress of arterial wall when finger is identical with the heart level position, but does not hinder blood flow.Preferably be about 70mmHg in the above in the example that this predetermined pressure is described.

The blood pressure ripple that is produced by measured's heart beating makes the arteries expansion at finger place and shrinks, and arterial vascular expansion and shrink the pressurizing

chamber

35 and 36 of finger detecting head 2a will be shunk and expansion.Final pressure variation at these intracavity is sensed by pressure transducer 14, and A/D converter 22 becomes digital signal with the conversion of signals of sensing, and signal is handled by processor 23, and demonstrates the continuous blood pressure measurement result on monitor 24.

The advantage that adopts annular to add crimp 40 is, it makes by end cover 30 applied pressure fields and has extended beyond beyond the finger change in volume measuring position, and the border of actual measurement location is in the pressure span of utilization fully like this.

Typical data

The output of system can be presented on the suitable monitor, wherein can suitably show selectable value on the monitor, systolic pressure, diastolic pressure and mean pressure as in the scheduled time.Except shows signal,, can also sample to blood pressure-time data and be stored in the memorizer of computer with preset frequency for the usefulness of later data retrieval.

In Figure 24, curve A representative is sensed by upright position pick off 19 and transducer 21, for the first time with the variation of measured's finger static pressure when raise the position of hanging low.It will be appreciated that from curve A when measured's finger was positioned at highest point, static pressure was maximum negative pressure value; In the process of position, static pressure rises gradually to be reduced to " zero " that flushes with heart at hands, reaches maximum malleation value when the finger as the measured is positioned at extreme lower position.Raising the static pressure that produces reverse order in the extreme higher position process that is back to it when hands changes.Preferably this process repeats twice, and averages.

Chamber 35, the 36 pressure output that the curve B representative is caused by the finger place change in volume of measured in the end cover 30, wherein the variation of measured's finger place volume should with the blood pressure phase of wave that is produced by measured's heart beating.

Like this, shown in curve B, when measured's finger was in the highest upright position, maximum negative hydrostatic pressure (curve A) was pressed with the calculating that measured's arterial pressure sum is offset 70mmHg inadequately, gets clogged at the tremulous pulse that shrinks and relaxing period is pointed like this.When the measured reduced finger, static pressure (curve A) became and no longer is so big negative pressure, and tremulous pulse is located to open for the first time at pressure crest (systole) like this, and locates to open once more at pressure trough (relaxing period).Like this, the shrink pack winding thread SE that defines at the crest place of curve B and at the diastole envelope DE at trough place.Relaxing period end points DP can be defined as the no longer smooth point of part in latter stage of single pulse wave, i.e. the no longer tangible point of relaxation signals in the pulse wave of noting when arm reduces more completely.Contraction end points SP is the point that first signal of pulse wave when reducing arm begins to occur.In the above two kinds of cases, shrink beginning and diastole when beginning all to appear at corresponding envelope SE and DE and beginning to rise.Also can shrink and diastole envelope mutually isochronous 2 points on volume, diastolic pressure be added at 2 pressure reduction of locating between two envelopes determine constriction point SP by finding.

Shown in Figure 25 is how to adopt the shrink pack winding thread SE of this formation and the blood pressure that diastole envelope DE converts the change in volume in the

chamber

35 and 36 that measures to the measured under the another kind of situation.Like this, in Figure 25, the shrink pack winding thread DE part of curve D E representative when the contraction process medium-sized artery begins to open.In this case, this constriction point represents that finger is lower than about 13 centimetres of heart level position, and this moment, static pressure was-10mmHg.Because the external pressure that applies is 70mm, then diastolic pressure is 70-(10) in this case, or is expressed as 80mmHg.

In example shown in Figure 24, to begin open constriction point place pressure be that (70mm of external pressure adds static pressure-45mm) to 115mmHg to tremulous pulse when shrinking.In Figure 25, the shrink pack winding thread SE part above diastole point should increase 45mm, and as the SE ' that shows among Figure 25, the contraction end points of Que Dinging is 80+45 like this, or is expressed as 125mmHg.

After in case equipment is calibrated as described above, can be kept in the memorizer of processor 23 (for example as lookup table or multinomial equation and store) by curve shown in Figure 25, the volume that measures like this can convert arterial pressure to automatically before being shown on the monitor as time function.

As can be seen, after in case equipment is calibrated as described above, then this equipment can with no wound mode will measure corresponding to the variation conversion of measured's finger place blood flow of blood pressure ripple and on monitor 24, be shown as complete pressure pulse wave (wherein measured's blood pressure ripple comprises systolic pressure and diastolic pressure) so that observer's continuous monitoring.

In carrying out the process that continuous blood pressure measures, the measuring position with respect to the vertical displacement of heart level position by continuous monitoring.The static pressure that departs from the heart level position is constantly deducted from blood pressure data, and Shi Ji result is by the static pressure offset correction like this, and blood pressure is shown with the form after proofreading and correct.

Comparing data

Figure 26 and 27 is depicted as the new technique that is used to measure blood pressure, the particularly top comparing data of comparing with the standard-sphygmomanometer measuring technique about the description of Figure 23-25.Contraction that new device is reported out and diastole value are respectively the value of determining from previously described calibration technology, wherein this calibration technology is determined to shrink and the diastole value.Given value is twice definite meansigma methods among the figure.

Standard pressure value (three definite meansigma methodss) is before device measuring of the present invention or the value of measuring immediately after measuring.The data of two kinds of methods are all measured from same arm.Because method of the present invention is to be used for determining measured's contraction and diastole end points, therefore decision compares with the no wound type blood pressure measurement of standard, and does not compare with the intra-arterial measurement that has technical difficulty that operates.Data result shown in Figure 26 and 27 is that they all have normal type to 18 measured (12 male, 6 women's) measurement, and the age is 23-60 year, and blood pressure normal (systolic blood pressure is 100-143, and diastolic blood pressure is 61-86, and pulse pressure is 31-64).Figure 26 comprises the meansigma methods of the systolic pressure, diastolic pressure and the pulse pressure that measure according to the present invention and the block diagram of SD (standard deviation).Although standard deviation of the present invention is higher than as correlated standard method, this allows in actual measurement.The deviation of novel method can be big, because the known standard method is that the variation of blood pressure between the heart beating is assessed, this is because its release pressure gradually.

Figure 27 relatively gets the scatterplot of data for new technique and standard technique.Can find out once more that from figure the data that are used between comparative standard method and the method for the present invention are linear correlation.Correlation coefficient (R=0.938) highly significant.

Although invention has been described and show relevant preferred embodiment; set up experimentation; but should be clear, to one skilled in the art, can under the situation of protection domain that does not exceed the claim qualification and marrow of the present invention, make amendment to details of the present invention.

Claims

1. equipment that is used to monitor measured's arterial pulse wave comprises:

2. equipment as claimed in claim 1, what wherein said measuring device was measured is the described far-end and the corresponding change in volume of blood pressure ripple of finger or toe.

3. equipment as claimed in claim 1, wherein said pressure applicator applied pressure is 70mmHg.

4. equipment as claimed in claim 1, what wherein said measuring device was measured is finger or the described far-end of toe and the variation of the corresponding optical density (OD) of blood pressure ripple.

5. as each described equipment among the claim 1-4, the static pressure field of force that wherein said pressure applicator applies around the far-end of finger or toe from the position of measuring described variation with towards the direction of heart proximal extension one preset distance toward finger or toe.

6. as each described equipment in the claim 1 to 4, wherein said pressure applicator comprises:

Wherein said deformable tubular film is divided into a plurality of parts.

7. equipment as claimed in claim 6, wherein said deformable tubular film are divided into two parts of the radially relative both sides that are positioned at the measured's finger this place admitted or toe.

8. equipment as claimed in claim 6, wherein said overcoat is divided into a plurality of parts, connects together with each described membrane portions separately, and limits described outer tubular chamber with described membrane portions.

9. equipment as claimed in claim 6, wherein said tubular film is divided into described a plurality of part by installation containment rod on the coat, this containment rod has a mid portion that is contained in the tubular film, thereby in the inside motion of the outer periphery that when described tubular cavity applies described pressure, suppresses each membrane portions.

10. equipment as claimed in claim 1, the pressure limit in the static pressure field of force that wherein said pressurized source provides are from 30mmHg to 70mmHg.

11. equipment as claimed in claim 1, wherein said equipment comprise that also one will be pointed or the variation of the described amount that records at the described outboard end place of toe converts the transducer of measured's arteriotony to.

12. equipment as claimed in claim 11, wherein said transducer comprises:

13. equipment as claimed in claim 11, wherein said equipment also comprise a pre-heater, this pre-heater is used for described finger or toe are preheated to predetermined temperature, thereby the arteries at described finger or toe place is at utmost expanded.

14. equipment as claimed in claim 1, wherein said pressure applicator are combined at least one fingerstall of the glove that had on by the measured, and measure measured's finger tip in this fingerstall be inserted in glove corresponding to the variation of blood pressure ripple.

16. equipment as claimed in claim 15, wherein said sleeve pipe also comprises a pressure applicator, this pressure applicator is used for applying a static pressure field of force around the far-end of finger or toe, the pressure of this pressure field enough prevents the alluvial of venous blood, and can when finger or toe and heart are in same horizontal level, partly eliminate the tension force of finger or toe place arterial wall, but obstructing arterial not.

17. as claim 15 or 16 described equipment, wherein said measuring device is measured is the change in volume corresponding to the blood pressure ripple at the distal portions of finger or toe.

18. as claim 15 or 16 described equipment, wherein said measuring device is measured is that the optical density (OD) corresponding to the blood pressure ripple at the distal portions of finger or toe changes.

20. be used for monitoring the dormant equipment of measured, comprise:

21. as claim 19 or 20 described equipment, wherein said measuring device is measured is the change in volume corresponding to the blood pressure ripple at the outboard end of finger or toe.

22. as claim 19 or 20 described equipment, wherein said measuring device is measured is that the optical density (OD) corresponding to the blood pressure ripple at the outboard end of finger or toe changes.

23. as claim 19 or 20 described equipment, wherein said pressure applicator applied pressure scope is 30mmHg to 70mmHg.

24. as claim 19 or 20 described equipment, the static pressure field of force that wherein said pressure applicator applies around the finger or the far-end of toe from the position of measuring described variation with towards the direction of heart proximal extension one preset distance toward finger or toe.

25. as claim 19 or 20 described equipment, wherein said pressure applicator comprises an overcoat, this overcoat has an installation deformable tubular film within it, this tubular film limits an outside tubular cavity with overcoat, and described tubular sleeve is used for admitting the measured to point or the described far-end of toe;

26. equipment as claimed in claim 25, wherein said deformable tubular film are divided into, and the measured who is positioned at this place admittance points or two parts of the radially relative both sides of toe.

27. equipment as claimed in claim 25, wherein said overcoat is divided into a plurality of parts, connect together with each described membrane portions separately, and limit described outside tubular cavity with described membrane portions, each described membrane portions formation has four lateral films, and the neighboring of the overcoat part that this film is corresponding with it in its neighboring is fixed together.

28. equipment as claimed in claim 25, the containment rod that wherein said tubular film is mounted on the coat is divided into a plurality of parts, this containment rod has the mid portion that is contained in the tubular film, thereby when the inside axially-movable of outer periphery that when described outside tubular cavity applies described pressure, can contain each membrane portions.